Medical Device, Quality/Risk Management, Submission & Registration, Worldwide Regulatory Affairs
PerkinElmer is a global technology company focused on improving the health and safety of people and the environment. The Regulatory Affairs Senior Manager will support our Diagnostics Business that focuses on products targeted to improve human health. He/she will represent regulatory submissions on global cross-functional teams providing guidance on US regulatory requirements, review data for sufficiency and lead registration related negotiations.
Preparation and timely completion of FDA submissions for in vitro diagnostic devices (assays, instruments, software) to meet project and business needs (Pre-Submission, 510(k), de Novo, PMA supplement, PMA annual report, etc.)
Participation on cross functional project teams to provide strategic and tactical guidance to meet US FDA requirements,
Development of regulatory plan for US submission and/or global regulatory plan for US manufactured IVD products
Assessment and applicable documentation of changes in product, manufacturing processes, labeling affecting IVD products distributed in the US, including communication to global Regulatory and project teams for impact assessment
Support global Regulatory teams and/or in-country dealers/representatives with regulatory registrations of US manufactured IVD products
Maintain up-to-date knowledge of US IVD regulations and applicable guidances, monitor development of regulations and communicate impact to the business
Provide input and feedback on clinical study protocols to ensure US regulatory requirements are incorporated
Act as FDA liaison for US submissions and other interactions regarding regulatory matters, including preparing for and attending meetings with the FDA as required
Support CE marking activities for US manufactured IVD products
Review and approve promotional materials and product labeling
Prepare USDA importation / exportation permits
Prepare export notification to FDA
Manage the day-to-day activities of the Regulatory Product Release system (product classification, set up of licences, release of orders, etc.)
Bachelors Degree in life science related field (Medical Technology, Clinical Chemistry, Biology)
Minimum of 5 years of experience in managing all aspects of preparing and filing FDA submissions for IVD and/or medical devices and overall 10 year direct industry experience
Excellent understanding of FDA regulations and guidance documents required
Previous experience supporting international registrations (FDA, CE) required
RAC certification preferred
Limited travel (up to 10-15% of the time, or as circumstances dictate)
Excellent interpersonal, verbal and written communication skills (in English)
Excellent time management, organizational, negotiation, and problem solving kills
Ability to work independently and in a matrixed organizational structure, developing strong relationships with peers and levels of management
Competitive compensation plan / Top notch training and development / Comprehensive benefits package / Paid time off and holidays / Generous tuition reimbursement plan / 401(k) with match and immediate vesting / An environment that fosters career growth.
PerkinElmer is an equal opportunity employer
Internal Number: JR-003472
With about 11,000 employees serving over 150 countries, PerkinElmer is a $2.3 billion global leader committed to innovating for a healthier world. We are passionate about providing customers with an unmatched experience as they help solve critical issues especially impacting the diagnostics, discovery and analytical solutions markets.
Our innovative detection, imaging, informatics and service capabilities, combined with deep market knowledge and scientific expertise, help customers gain earlier and more accurate insights to improve lives and the world around us.