Description :
Overview :
Reports to Vice President, Regulatory/Clinical Affairs, and provides regulatory, technical and clinical support with respect to new product introductions, product modifications and complaint handling.
Responsibilities :
Determining appropriate regulatory requirements and strategies for the release of new and/or modified medical devices.
Preparing and submitting all required documentation of all pre-market notifications (eg. applications to the FDA for marketing of new/modified medical devices, PMA, 510(k)'s, etc.).
Assisting in the development of product labeling instructions and promotional materials and review labeling/advertising for compliance with medical device regulations.
Ensuring division compliance with Corporate Regulatory and Medical Affairs requirements.
Determining and preparing appropriate international filings and registrations.
Participating in new product development teams to provide direction with respect to regulatory requirements.
Special projects as assigned.
Qualifications :
B.S. degree in Life Science.
2-3 years relevant experience including submission of IDE's, PMA and 510(k) documents.
Knowledge of biostatistics and computer database development.
Strong oral and written communication skills.
Some Travel Required