Biopharmaceutical Positions2618 Senior QSR Engineer : Medical Device Life Cycle California
2605N Medical Device Clinical Research Manager Boston area
2599 Manager MRI Surgical Navigation Product Support Australia
2597 Pre-clinical (Animal Phase) Account Manager New England
2578N Sports Clinic Manager: Physiotherapist or Chiropractor BC
2451 Sr. CRO Study Director Preclinical Toxicology Montreal
Job ID: 2618
Position: 2618 Senior QSR Engineer : Medical Device Life Cycle California
Location: San Diego, CA
Description: Southern California medical device company is looking for a Senior Quality QSR Engineer re medical device product development and transfer to market. ROLE AND RESPONSIBILITIES: - Supporting and guiding product development and mentoring teams through the design life cycle, and transfer of product into manufacturing. - Post market surveillance monitoring ensuring compliance with the Quality System Regulations, 21 CFR Part 820, and ISO 13485. - Balancing business objectives and quality requirements to determine readiness of projects to proceed to the next phase. - safety, efficacy and hazard analysis [SHA], failure modes and effects analysis [FMEA] - use same to drive improvement in Quality Metrics such as product development cycle time. - Do technical reviews and/or develop key documents including quality and reliability plans, FMECA, design reviews, design verification and validation plans/reports, product and process validation, pilot runs and sample size justification. - Change Request approval, ensuring accuracy and adequacy. - Developing inspection criteria for components and finished devices. - Doing supplier audits pertaining to R&D supplier selection process-supplier part and process qualifications and validations. - Providing input to budget, planning, and evaluation processes. - Assisting R and D to verify that; modifications to the manufacturing processes and/or product design do not affect product suitability for its intended use. - IQ, OQ, PQ of new equipment and processes. - Comply with relevant FDA QSRs and ISO regulations. REQUIREMENTS: BS Electrical Engineering/other engingeering preferred. ASQ (CQE, CRE, CQA) Certifications a plus. 5 to 7 years as a Quality/Reliability Engineer, Design Engineer working within the framework of a Quality System. Experience with medical device manufacturing with electronic and/or electromechanical products preferred. Risk management background Management experience not necessary. NO VISAS.
Job ID: 2605N
Position: 2605N Medical Device Clinical Research Manager Boston area
Location: Boston, MA
Description: Our client, a leader in the medical device arena, is presently conducting clinical trials on some of their newer laser devices. They require a clinical research manager / project manager to assume a leadership role in the supervision of trials at a number of sites in the Boston area. ROLE AND RESPONSIBILITIES: - Leading, coordinating a variety of trials at 6 to 10 different clinical sites, at different device life cycle stages - Help study directors / CRAs plan/design all protocols and related study documents. - Interact with CRAs, Clinical Data Managers, physicians, nurses to coordinate their studies, monitor progress, and prepare status reports. - Bearing FDA compliance in mind, make sure trials comply with GCP requirements. - Help team work with Regulatory Affairs; set up audit procedures to make sure studies meet regulatory objectives and that the data will support regulatory filings. - Together with the data managers, make sure that only "clean" data appears in the database. Note that this client runs a paper based system, so the process should be clean and simple. - Able to take a more hands-on role in coordinating study sites based on resources and requirements. REQUIREMENTS: B.Sc. (Nursing B.Sc.N) preferred and clinical certification - such as CCRP, CRP, SoCRA nice to have. Real experience with FDA regulations and GCP, related to medical device trial. Background managing trials, people, and training and mentoring staff. 2 to 5 years working in trials related to medical device. Able to write protocols, multitask, work in a team or solo. Background working with doctors and staff. Best if candidate understands the process of medical device development. 30% travel. Need to be living in MA, to be close to sites in question. Type of personality that will fit into very active, energetic group. Must be able to interact with people at a high level and be the face of the company. 30% travel.
Job ID: 2599
Position: 2599 Manager MRI Surgical Navigation Product Support Australia
Location: Sydney, AUS
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 Sydney, responsible for APAC: East Asia, South Asia, Southeast Asia, and Oceania. Reports to a Director. This is a rapidly growing organization, with regulatory approval for its cutting edge technologies in many countries worldwide. You would be joining a team of successful scientists and business people who have founded and transitioned many successful medical device start-ups into world markets. Remuneration will be in your local currency. 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 (surgical navigation), optics and robotics. - Previous education / training experience related to Services & Implementation for medical equipment. - Service background Ð biomedical education or experience and has to be in medical device. - History working with medical device capital equipment. - Experience in the Operating Room (OR) background re medical devices working with operating staff. - Excellent customer service, troubleshooting, communication, team player, leadership skills. - Multilingual Highly Beneficial. - PACS, DICOM. MOST IMPORTANT: - Experience with medical device capital equipment - Servicing and case support experience - Ability to travel 50-75%.
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: 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: 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.