HireDiversity

Raynham, MA, US

Project Manager, Regulatory Affairs (1 of 2)-1427130207

Description

DePuy Synthes Spine, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Project Manager, Regulatory Affairs, 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 Project Manager, Regulatory Affairs 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 proactively devise strategies for front end projects as well as ensure consistency in regulatory strategies in NPD and base business project teams to ensure rapid and timely approval of devices and continued regulatory support of marketed devices. This individual will participate and provide guidance and support to product development teams on both US and international issues. The Project Manager, Regulatory Affairs will review and approve product literature and promotional pieces. He/she will review and provide regulatory authorization for any Custom or Special Requests. This individual will review and analyze technical data generated by Research and Development, Marketing/Sales, Clinical Research, Quality Assurance or other related departments. The Project Manager, Regulatory Affairs will assist team with up-classification of Spinal implants in the EU. He/she 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. This individual 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. The Project Manager, Regulatory Affairs will review and approve product labeling and promotional pieces; main point of contact for any advertising and promotion related issues, ensure consistency in A&P reviews across team. This individual will work with WW Sterile IFU team and represent Spine RA on the electronic labeling initiative, as well as other cross franchise or cross sector project teams. The Project Manager, Regulatory Affairs will be responsible for any Regulatory compliance related issues and working directly on global quality remediation plan.

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Qualifications


A minimum of a Bachelor's Degree is required. A Bachelor's Degree in a scientific discipline is preferred. An Advanced Degree preferred. A minimum of 8 years experience working in a Regulatory Environment preparing submissions for Class II/III medical devices and a successful track record is required. Candidates are required to have specific experience in the preparation, and submission of 510(k)'s, IDEs, PMA supplements, as well as Technical File and Design Dossier experience. Solid Knowledge of US and European regulatory process, including Class III devices is required. Excellent written, verbal communication and presentation skills, including experience presenting at FDA meetings is required. 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 20% travel.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-Massachusetts-Raynham
Organization: Depuy Orthopaedics. Inc. (6029)
Travel:Yes, 25% of the time