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Regulatory Affairs Specialist III (1 of 2)-1334130206
DePuy Synthes Spine, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Regulatory Affairs Specialist III, 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 will 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, we are creating one organization that will be agile and better equipped in 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.
DePuy Synthes Spine is the Spine business offering a comprehensive portfolio of spinal care solutions for the treatment of the most simple to the most complex spine disorders using traditional and minimally invasive techniques.
The Regulatory Affairs Specialist III will 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. He/she will work with management to devise strategies to ensure rapid and timely approval of devices and continued regulatory support of marketed devices and other products. This individual will participate and provide guidance and support to product development teams on both US and international issues. He/she will review and approve labeling, manufacturing, marketing and clinical protocol procedures and documents. This individual will review and provide regulatory authorization for Engineering Change Orders (ECOs). He/she will review and analyze technical data generated by Research and Development, Marketing/Sales, Clinical Research, Quality Assurance or other related departments. The Regulatory Affairs Specialist III will submit Design Dossiers for up-classification of products in the EU. This individual will 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. A Bachelors Degree in a scientific discipline is preferred. An Advanced Degree is preferred. A minimum of 5 years experience working in a Regulatory Environment preparing submissions for Class II/III medical devices and a successful track record is required. It is required that individuals have specific experience in the preparation, and submission of 510(k)'s as well as technical files and/or design dossiers. Experience with Pre- IDEs, IDEs, PMA supplements or PMA, or HDE is preferred. Experience in spinal medical devices is preferred. A solid Knowledge of US and European regulatory process is required. Excellent written, verbal communication and presentation skills, including experience presenting at FDA meetings is required. The ability to communicate clearly, succinctly and effectively over the phone and in writing is required. Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive are required. Ability to work in a timeline-driven environment is required.
This position will be located in Raynham, MA and requires up to 10% travel.
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Primary Location: North America-United States-Massachusetts-Raynham
Organization: Depuy Orthopaedics. Inc. (6029)
Travel: Yes, 10% of the time
Johnson & Johnson Family of Companies - 10 months ago
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