Regulatory Affairs Submissions Specialist

Kensey Nash Corporation (NASDAQ, KNSY) is a medical device company known for providing innovative product development and advanced technology for a wide range of medical procedures. The Company has expanded well beyond its beginnings in vascular puncture closure and today provides an extensive range of products into multiple medical markets. We need your expertise as we continue to grow.

The Regulatory Affairs Submissions Specialist will provide regulatory guidance and support to product development projects including development of global regulatory strategies and preparation and management of global regulatory submissions.

Principal Duties Include:Assist in the implementation of Regulatory Affairs policies, programs, and proceduresDevelop and implement strategies for domestic and international governmental approval to introduce new medical devices to global marketParticipate in multiple cross-functional project teams by representing Regulatory Affairs at Product Development meetings and provide advice on regulatory requirements as neededPrepare domestic/international submissions for new products and product changes as required to ensure timely approval for clinical studies and market release [510(k), IDE, PMA, Investigator Brochure, Design Dossier, Master File, etc.]Review significant regulatory issues with manager, as necessary, and negotiate submission issues directly with agency personnel as requiredProvide on-going support to Clinical, Marketing, Manufacturing, Product Development and Quality teams for regulatory issues and questions and to ensure continuous regulatory compliance of clinical and commercial medical devicesProvide product and test information to Product Development in order to support domestic/international submissionsPrepare project status reports for management review as requested and to meet regulatory requirements as neededPrepare briefing documents for and participate in internal regulatory meetings and meetings with regulatory authorities as necessary

Qualified candidate with have Bachelors degree (life-science a plus); minimum 3 years prior experience in regulatory affairs, extensive experience with FDA and other regulatory submissions; knowledge of U.S. and European regulations a must; experience with medical devices desired; RAC (Regulatory Affairs Certification) desired; excellent technical writing, oral communication and negotiating skills; competence with Microsoft Office and data analysis ability required; ability to effectively manage and prioritize multiple projects; ability to work well in team environment. 

We offer an attractive compensation/benefits package, a creative working environment and an opportunity to join a strong team of highly skilled individuals.

 

Check out our website! www.kenseynash.com

 

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ONLY APPLICANTS WHO SUBMIT SALARY REQUIREMENTS WILL BE CONSIDERED FOR THIS POSITION