Biopharmaceutical Positions2598 Manager MRI Surgical Navigation Product Support Germany
2599 Manager MRI Surgical Navigation Product Support APAC
2597 Pre-clinical (Animal Phase) Account Manager New England
2589N Sr Medical Device QA Manager GTA
2594 Stem Cell Field Application Specialist Mtl/TO
2591 Manager Validation and Verification (Medical Device Software) GTA
2586 Pharma/Drug Regulatory Affairs Sr. Manager New England
2578N Sports Clinic Manager: Physiotherapist or Chiropractor BC
2575 Manufacturing / P&L General Manager Medical Device GTA
2551 Diagnostic Imaging FSE Specialist NYC
2456 Sr. GLP QA Auditor (Preclinical CRO) QC
2451 Sr. CRO Study Director Preclinical Toxicology Montreal
Job ID: 2598
Position: 2598 Manager MRI Surgical Navigation Product Support Germany
Location: Munich/Berlin, GER
Description: Toronto based medical device company developing MRI surgical suite imaging and navigational support products requires a Manager MRI Surgical Navigation Product Support - based in Germany, responsible for EMEA - Europe and Middle East. ROLE AND RESPONSIBILITIES: - Crucial to serve as the advanced product "expert", especially relating to new sites, new surgeons, and more complex procedures. - Management / Implementation of new systems, service, on-site repair, and maintenance (scheduled and stat). - Knowledgeable in the operation and clinical use of the systems. - Train, certify, and hand over to hospital staff, distributors, or sales reps. - Carry out training and certification activities for field based employees, distributors, and hospital personnel. - Support sales, working closely with the RSM. REQUIREMENTS: - BS Biomedical Engineering or related. - Background in MRI, intra-operative imaging, stereotactic navigation, optics and robotics. - Previous education / training experience related to Services & Implementation for medical equipment. - Operating Room (OR) background re medical devices. - Multilingual Highly Beneficial. - Excellent customer service, troubleshooting, communication, team player, leadership skills.
Job ID: 2599
Position: 2599 Manager MRI Surgical Navigation Product Support APAC
Location: AsiaPacific, APAC
Description: North American based medical device company developing MRI surgical suite imaging and navigational support products requires a Manager MRI Surgical Navigation Product Support - based in APAC, responsible for East Asia, South Asia, Southeast Asia, and Oceania. ROLE AND RESPONSIBILITIES: - Crucial to serve as the advanced product "expert", especially relating to new sites, new surgeons, and more complex procedures. - Management / Implementation of new systems, service, on-site repair, and maintenance (scheduled and stat). - Knowledgeable in the operation and clinical use of the systems. - Train, certify, and hand over to hospital staff, distributors, or sales reps. - Carry out training and certification activities for field based employees, distributors, and hospital personnel. - Support sales, working closely with the RSM. REQUIREMENTS: - BS Biomedical Engineering or related. - Background in MRI, intra-operative imaging, stereotactic navigation, optics and robotics. - Previous education / training experience related to Services & Implementation for medical equipment. - Operating Room (OR) background re medical devices. - Multilingual Highly Beneficial. - Excellent customer service, troubleshooting, communication, team player, leadership skills.
Job ID: 2597
Position: 2597 Pre-clinical (Animal Phase) Account Manager New England
Location: Boston, MA
Description: Our client, a leading and successful New England player in the pre-clinical research arena, is seeking a pre-clinical Account Manager, responsible for customers in Massachusetts, ON, and QC, based in the Boston area. Ideal candidate will have experience in pre-clinical research and a proven track record of building successful relationships with large Pharmaceutical / Biotech companies. OUTLINE: - As account manager, you will be expected to help preclinical research clients grow, and increase their need for company services and animals. - Your team will interact with other departments in the company and leverage their talents to help clients succeed in the pharmaceutical and biotechnology arena - meeting their needs and expanding their businesses. - Responsible for departments such as in vivo pharmacology, reproduction, animal breeding, more. - You will be able to network in the assigned territory, including within complex institutions, to present the entire product portfolio appropriately, while finding solutions to customer problems. RESPONSIBILITIES: - Position products across all of the the company's business units at a high scientific level with a pre-clinical research focus. - Developing and nurturing the relationship between the company and new customers in the commercial space. - Managing existing relationships to ensure the company remains a highly valued partner in their research. - Actively managing an evolving pipeline and impacting deal closure. - Meeting or exceeding established territory revenue targets across all 4 business units. - Developing and maintaining strong customer relationships at multiple levels within the institutional and end user level. - Identifying and securing opportunities for growth within existing customers and prospective customers. - Collecting market intelligence for new product concepts and for identifying market trends. REQUIREMENTS: - BS/MS Life or Animal Sciences. - >5 years' progressive direct biomedical or animal science sales. - Excellent consultative selling skills and a proven capability to close technical sales in pre-clinical settings. - Strong verbal and written communication and presentation skills. Knowledge of salesforce helpful. - Driver's license and free to travel up to 60%. MUST HAVE: Understanding of animal models, molecular phenotyping/pathway reporter genes/ genotyping. COMPENSATION: Salary competitive, bonus, commission, car allowance, health, dental, life insurance, education, tax contribution, EAP, gym, more.
Job ID: 2595N
Position: 2589N Sr Medical Device QA Manager GTA
Location: Toronto, ON
Description: West end Toronto OEM medical device company is looking for a Senior Quality Assurance Manager, who can lead the development and be responsible for a quality management system, QMS, ensuring that all operations comply with ISO, US, Canadian, European, other regulatory bodies. The company manufactures and sells its own products as well as serving as a CMO for other clients. This position would encompass oversight of both QC and QA, related to medical device and any associated software. ROLE AND RESPONSIBILITIES: - Quality management systems and subsystems ownership. - Support of design control, process validation, in an OEM environment. - QC testing, evaluating stability of product, process validation, OOS reports. - Experience obtaining certifications such as MDSAP, ISO 13485. - V&V testing. - Risk management, audits, implementation of unique device identifiers. - Metrics. REQUIREMENTS: - B.Sc./BS. - 5 to 10 years in the medical device, life sciences, or clinical diagnostics industry. - Background working in a product development environment with quality manufacturing occurring on site. - Worked within a medical device, clinical diagnostics, or life sciences company and has led quality initiatives. - Experience in an ISO 13485 or FDA QSR environment. - Quality management expert - not limited to software, able to lead both QC and QA. - Able to see the big picture in quality issues across the manufacturing enterprise. - Experience doing risk assessment, process validation, design control. - Quality professional in a product development environment; QMS initiatives linked to manufacturing. - Strong communication, problem solving, computer literate individual -Prefer a CQA with some start-up experience.
Job ID: 2594
Position: 2594 Stem Cell Field Application Specialist Mtl/TO
Location: Toronto/Montreal, CAN
Description: Our client is a recognized player supplying Canadian and US laboratories - Academic, Government, Biopharma, Industrial. Products such as equipment and reagents, including molecular biology products, cell media, chromatography, protein chemistry, DNA and protein markers, nucleic acid purification technologies, Western blots, stem cell technologies, small lab equipment, and related. They are seeking a Stem Cell Field Application Specialist - to be based in either Montreal or Toronto. Home based. DESCRIPTION: - Helping clients trouble shoot and optimize protocols. - Anticipating customer requirements. - Educate sales staff and customers on existing and new product use. - Be aware of the competition and the value-add of the company's offerings. - Demos, presentations. - Represent company at meetings, conferences, trade shows. REQUIREMENTS: M.Sc. or Ph.D. Biochemistry, Life Sciences, Cell Biology, related. Experience with mammalian tissue culture is a must. Min 5 years' research experience with human stem cell culture. Knowledge of related stem cell products. Excellent English language, interpersonal, communication, organization, presentation skills. Ability to impart technical information - e.g. to sales staff and customers. French skills would be an asset.
Job ID: 2591
Position: 2591 Manager Validation and Verification (Medical Device Software) GTA
Location: Toronto, ON
Description: North Toronto medical device OEM/R&D company has a full time position for an experienced Manager of Validation and Verification. You will be involved in the guidance of all phases of medical device software and hardware testing during product development and afterwards. ROLE AND RESPONSIBILITIES -Manage all test staff and be able to teach and mentor staff. -Ability to plan and execute testing activities and projects. -Talent for automating the testing of components . -Supervise all verification and validation aspects of product development and provide support when required regarding integration, regression, verification and validation and results analysis. -Oversee testing records, including defects, problems of hardware and software and their resolution. -Assist engineering department to plan and carry out product development. -Establish time lines, review meetings, review test plans and reports. -Participate in document control and interdepartmental collaborations, -Provide corrective action planning - for both customers and management. -Establish policies and procedures, H&S, legal requirements, change orders. -Review and establish process validation, automated testing, quality issues and procedures as required. -Relentlessly pursue continuous improvement opportunities. REQUIREMENTS -Education: 4 year B.Sc. preferably in Science, Engineering or related discipline. -8 years' (post graduation) work history related to planning and executing testing activities on medical device software, hardware, ultrasound imaging, electronics and complex systems in progressively upward positions. -Experience working with subordinate staff, including managing, directing, evaluating and mentoring. -Thorough understanding of test methodology, including test plans, system and integration level testing, and status reporting. -Experience with automated test regression tools experience (e.g. WinRunner, HiTest, .). -Experience with defect tracking software package. -Knowledge, skills, training, and experience in both Windows NT and UNIX software engineering environments using C++, C, and Visual Basic is an asset. -Experience in all aspects of product development. -Thorough knowledge of software quality and regulatory standards such as ISO 13485 / EN 46001 and FDA Quality System Regulations. -Experience with risk assessment and management using formal procedures or regulatory standards such as ISO 14971. -Thorough understanding of traceability between risks, product requirements, product design, implementation, test procedures, test results, and risk mitigation. -Training in quality assurance and auditing of QA systems is an asset. - Excellent communication and organization skills. -This is an on-site position near North Toronto, Newmarket, Vaughan. .
Job ID: 2586
Position: 2586 Pharma/Drug Regulatory Affairs Sr. Manager New England
Location: New England, NE
Description: New England pharmaceutical company is looking for a Sr. Manager for its Regulatory Affairs department. In this role, you will be responsible for worldwide strategy, related to successful submissions, and domestic and international approvals for drug products. ROLE AND RESPONSIBILITIES: - International and domestic strategies for document submissions, project and drug product approvals, labeling, clinical trials, marketing. - Team supervision, regulatory representative at internal and external meetings. REQUIREMENTS: M.Sc., Ph.D., DVM, PharmD preferred. RAC nice to have. Experience in drug pharmaceutical regulatory affairs - 10 years - may consider slightly less. Management of people and team - best at very senior manager or director level. Background with FDA and international bodies. Best to have worked with products, and documents for products, on or coming to market. Able to relocate to New England as required.
Job ID: 2578N
Position: 2578N Sports Clinic Manager: Physiotherapist or Chiropractor BC
Location: Kelowna, BC
Description: We are recruiting for a Manager for a BC multidisciplinary sports clinic. The successful candidate will be an experienced and BC licensed physiotherapist or chiropractor. Company will relocate as required. RESPONSIBILITIES: The Clinic Director is responsible and accountable for the leadership and overall success of the clinic. Oversees all internal operations related to clinical quality, staff development and patient satisfaction. Drives financial performance through business development activities and customer service. This role will appeal to physiotherapy or chiropractor candidates who are seeking a career opportunity and are committed to the delivery of excellent clinical services and the professional development of a high performance team. Aggressive growth strategies and patient satisfaction are key business indicators. DUTIES AND RESPONSIBILITIES: Ensures quality improvement in the delivery of patient care. Performs chart audits, maintains standards for communications, participates in education programs both internal and external. Adheres to effective and efficient clinic and corporate operating procedures. Maintains a partial clinical caseload. Responsible for annual business plan. Monitors financial performance, customer service programs and patient/physician satisfaction. Demonstrates leadership and expertise through mentorship. Develops corrective action plans when necessary. QUALIFICATIONS: Registered member in good standing with PT or Chiropractic BC professional college. Undergraduate university degree and related post graduate credentials. Minimum 5 years of clinical experience. Strong communication and problem solving skills. Effective listener, goal orientated, good people skills.
Job ID: 2575
Position: 2575 Manufacturing / P&L General Manager Medical Device GTA
Location: Woodbridge, ON
Description: A Toronto area small manufacturer of medical devices and involved in designing, manufacturing and assembling products for the medical community is looking for a General Manager, Manufacturing. The focus of this position is P & L as well as strategic planning, regulatory oversight, customer development and overseeing new product designs. RESPONSIBILITIES: - Manage sales, engineering, manufacturing, supply chain, and new product development with total Profit and Loss responsibility. - Ensure products meet ISO 13485 and ISO 9001 standards. - Introduce policies and programs affecting the scheduling, quality and cost of manufactured products. - Provide leadership to various areas of the organization. - Adapt leading edge technology to meet the company's competitive advantages. REQUIREMENTS: - BS Engineering education, and manufacturing management background. - Minimum of 5 years managing P&L with a track record of profitable growth in manufacturing. - History of strategic initiatives to insure profitable growth. - Experience with ISO 13485 and ISO 9001. - Working with integrated IS/MRP/Accounting systems as well as shop floor planning aids. - Totally prefer background in medical device, but aerospace or automotive considered. - Strong Customer and Quality focus
Job ID: 2551
Position: 2551 Diagnostic Imaging FSE Specialist NYC
Location: New York, NY
Description: Prestigious Manhattan health care center is recruiting for a diagnostic medical imaging instrumentation repair specialist. ROLE AND RESPONSIBILITIES: Maintain, repair medical imaging equipment routinely used for heart, brain, other imaging, such as X-Ray, Fluoroscopy, MRI, CT, ultrasound, nuclear medicine. REQUIREMENTS: BS Electronics/B.Eng./BS Biomedical/ OR A.S. Degree in related field. 3 years doing biomedical instrumentation medical imaging equipment maintenance and repair. One year up-to-date, recent or current work. Focus on medical imaging modalities, not other types of hospital lab equipment such as analyzers, etc. any knowledge of PACS/RIS very helpful. Excellent English, organizational, interpersonal, team player skills.
Job ID: 2456
Position: 2456 Sr. GLP QA Auditor (Preclinical CRO) QC
Location: Montreal, QC
Description: Montreal CRO preclinical testing laboratory seeks a GLP QA Auditor to monitor studies, systems, data, and procedures to make sure that work is done in compliance with GLP. ROLE AND RESPONSIBILITIES: - Audit toxicology study plans, reports, raw data re completeness, accuracy and GLP compliance. - Investigate the critical phases of all preclinical studies re method validation, sample analysis for compliance with study plans, to ensure compliance with SOPs, GLP. - Attend an average of 4 necropsies procedures per month. - Write inspection reports, finalize reports and audit sub-contractors. - Communicate non-compliance to study personnel, directors, and management and recommend corrective action. - Audit facility/laboratory as required. - Make sure there are written and signed records of auditing activities. REQUIREMENTS: B.Sc. or DEC with several years working in a GLP unit. QA inspection/audit experience with respect to toxicology and related preclinical studies. Must be willing to attend necropsies. Excellent comprehension of Good Laboratory Regulations. Able to train others. Strong English and French communication skills. Detail oriented with excellent interpersonal, organizational, or team player skills.
Job ID: 2451
Position: 2451 Sr. CRO Study Director Preclinical Toxicology Montreal
Location: Montreal, QC
Description: Montreal, QC preclinical testing laboratory seeks a Toxicology Study Director to be responsible for toxicological (GLP) investigation of pharmaceuticals. ROLE AND RESPONSIBILITIES: Designing protocols and programs. Overseeing all technical and scientific activities and in-life monitoring. Responsible for overall conduct of pre-clinical drug studies. Communicating with sponsors. Interaction with internal (QA, Bioanalytical) and external customer/s Writing reports, protocols, and evaluating data. Serving as the scientific representative on corporate committees. Attending scientific meetings. Training of junior technical and scientific personnel. Carry out R&D in line with company objectives. REQUIREMENTS: BSc. (min) plus 5 years as a Tox Study Director in the CRO, biotechnology, OR pharmaceutical industry. Experience with safety studies of biologics and drugs. Background in the review and tabulation of study data (PK analysis). Knowledge of ADME studies (Absorption, Distribution, Metabolism and Excretion). Able to provide quotes for new incoming studies. Excellent organizational, protocol and report writing skills, working knowledge of GLP, SOPs. Please note that this is GLP, not GMP or GCP. Hands-on, able to deal with the animal experimentation side of testing. French / English bilingual nice to have.