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Job #03075

About our client Our client is an leading diabetes management company based in Bedford MA. They focus on providing superior treatment options and lifelong health benefits for people with diabetes. Our client’s employees have extensive knowledge and experience in the diabetes and medical device industries. Their first marketable product is a new insulin blend. It brings together all of the functionality of a predictable insulin pump and blood glucose monitor into a system that features no tubing and automated cannula insertion. With a leading product on board and an experienced management team, this is an excellent opportunity for the right person to join a dynamic and rapidly growing company. Position Location Director of Regulatory and Clinical Affairs Bedford, Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Establish and direct maintenance of internal systems for regulatory approval of medical devices in domestic and international markets 2) Compile and submit documentation (as required) in support of marketing initiatives 3) Design, support and implement clinical studies based on sales and marketing initiatives for use of clinical data to support product outcomes or regulatory requirements 4) Manage the clinical and user study trials and ensure proper implementation, GCPs and appropriate statistical analysis for use in claims, submissions or advertising 5) Provide direction to the department and to the company in the planning, organizing and interpreting of regulatory documents 6) Determine the impact of product, process and labeling changes to regulatory submissions previously approved or cleared 7) Ensure that the quality systems comply with domestic and applicable international regulations 8) Manage the internal audit program and ensure timely closure on non-compliances 9) Perform other relevant duties as assigned by the management Requirements 1) BS in Biomedical Engineering, Biology or other related scientific field 2) 10 – 15 years of experience in the medical device regulatory field, with minimum 5 years of managerial experience and minimum 5 years related to clinical study development and implementation 3) 510(k), Class II or III device experience 4) Experience in quality system guidelines, CE Mark, Canadian Licensing and other international registration processes 5) Diabetes and related device experience a plus 6) Experience in auditing of quality systems for compliance is highly preferred 7) PMA submissions and related clinical trials experience preferred 8) FDA/international regulatory contacts and experience in successfully negotiating with the FDA and other regulatory bodies 9) Excellent communication skills 10) Ability to interpret regulations and provide creative, compliant solutions 11) Ability to interact with all levels of the organization (hospital personnel, patients, principal investigators, KOLs and the FDA)