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Specialist 3, Regulatory Affairs
Requisition ID: 4339180226
Mitek Sports Medicine, part of the DePuy Synthes Companies of Johnson & Johnson is recruiting for a Specialist 3, Regulatory Affairs - Mitek Sports Medicine located in Raynham, MA.
DePuy Synthes Mitek is the Sports Medicine business offering orthopaedic sports medicine products, soft tissue repair devices, joint movement solutions and minimally invasive and arthroscopic solutions.
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 have created one organization with a focus on activating insights to develop innovative, comprehensive healthcare solutions.
The Regulatory Affairs Specialist III as part of the Center of Excellence Digital Platform is responsible for contributing to the Regulatory Affairs team in providing regulatory advice and develop global regulatory strategies to support project team and will be the regulatory representative on specific multidisciplinary teams.
- This position will prepare 510(k)'s, Design Dossiers, and STeDs to support worldwide registrations as deemed necessary.
- Will be responsible for interacting with regulatory authorities as necessary.
- Assures that all submission documentation, record keeping and reporting meet inspection standards in accordance with regulatory requirements.
- May prepare responses to worldwide health authorities for submitted applications.
- Will stay abreast of all pertinent regulatory affairs issues.
- Other responsibilities include providing regulatory support for currently marketed products, including the review and approval of engineering drawings, labeling, technical files, design history files, and engineering change orders.
- A Bachelor’s Degree in a scientific or technical discipline, with a minimum of 4 years direct Regulatory Affairs experience within the medical device field, is required.
- Knowledge of electrical and electronic medical device equipment containing software is preferred.
- The candidate must have a demonstrated aptitude for preparing and submitting 510(k)’s in addition to preparation of EU Design Dossiers/Technical Files is preferred.
- Prior interaction with the FDA and Notified Bodies is preferred and other worldwide agencies preferred.
- Experience working with cross-functional teams is required.
- Candidate must have the ability to provide innovative solutions within the boundaries of regulation, have the ability to organize data and identify issues or gaps, and have the ability to effectively communicate in oral and written forms.
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)