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Regulatory Affairs Specialist II
Requisition ID: 8273180406
DePuy Synthes Companies of Johnson & Johnson is recruiting for a Regulatory Affairs Specialist II – Spine, located in Raynham, MA.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic 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
- Provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches in the global market
- Leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers, 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.
- Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.
- Defines data and information needed for regulatory approvals.
- Develops labeling specifications and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.
- Provide Regulatory Affairs support during internal and external audits.
- Plans schedules for regulatory deliverables on a project and monitors project through completion.
- Assists in the development of best practices for Regulatory Affairs processes.
- Represents Regulatory Affairs on cross-functional project teams, providing guidance and support to product development teams on both US and international issues.
- Partners with other functions to define and obtain data to assist with regulatory submissions.
- Review and provide regulatory authorization for Engineering Change Orders (ECOs).
- 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.
- A minimum of a Bachelor’s Degree is required, advanced degree(s) preferred.
- Educational background in scientific, business, or legal discipline preferred.
- Must have 2+ years working in medical device or regulated industry. Candidates with <2 years of practical experience who currently possess an advanced degree in Regulatory Affairs will also be considered.
- Knowledge of US and European 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.
- This position will require a minimum of 10% domestic/international travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Depuy Orthopaedics. Inc. (6029)