J&J Family of Companies Regulatory Affairs Specialist I – Spine, in Raynham, Massachusetts
DePuy Synthes Companies of Johnson & Johnson is recruiting for a Regulatory Affairs Specialist I – Spine, located in Raynham, MA.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own. To learn more, visit www.depuysynthes.com
Prepare US and International regulatory submissions, including, but not limited to 510(k)’s, IDE/IDE Supplements, PMA/PMA Supplements, Annual Reports, HDEs, IND/NDA Supplements, Design Dossiers/Change Notifications, and Technical Files.
Work with management to devise strategies to ensure rapid and timely approval of devices and continued regulatory support of marketed devices and other products.
Participate and provide guidance and support to product development teams on both US and international issues.
Review and approve labeling, manufacturing, marketing and clinical protocol procedures and documents.
Review and provide regulatory authorization for Engineering Change Orders (ECOs).
Review and analyze technical data generated by Research and Development, Marketing/Sales, Clinical Research, Quality Assurance or other related departments.
Submit Design Dossiers for up-classification of products in the EU.
Respond to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approvals in other countries, as well as provide routine regulatory information to associates and affiliates.
Support department activities by providing administrative assistance.
A minimum of a Bachelor’s Degree is required (scientific discipline preferred) with a minimum of 2 years working experience in the medical device or a regulated industry OR an advanced degree with <2 years of working experience in the medical device or regulated industry will also be considered.
Familiarity with US and European medical device regulatory processes is required.
Experience in the preparation and submission of US Regulatory files (510(k)s, PMAs) as well as European Technical Files and Design Dossiers is preferred.
Must have excellent written, verbal communication and presentation skills.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Depuy Orthopaedics. Inc. (6029)