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Senior Regulatory Affairs Specialist - Trauma Job

Company Name:
Depuy Orthopaedics. Inc. (6029)
West Chester, PA, US
Senior Regulatory Affairs Specialist - Trauma
Description
DePuy Synthes Companies of Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist - Trauma in West Chester, PA.
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.
Synthes Trauma offers a broad portfolio of orthopaedic fracture fixation products, including screws, plates, nails and other implants used to fix broken bones.
The Senior Regulatory Affairs Specialist - Trauma will provide regulatory support for assigned projects, both pre- and post-market. They interface with Product Development groups to discuss US, Canada, and EU regulatory requirements and pathways to market, and develop regulatory strategies for new/modified products. They will prepare and submit US FDA and Health Canada regulatory documentation for assigned products, including original submissions and any subsequent correspondence. They will engage regulators, when necessary, in oral communications to discuss pending or new submissions, regulatory requirements, etc. They will develop and propose regulatory pre-market strategies in cooperation with other departments, and other Synthes locations as dictated, and work cooperatively with Product Development groups to achieve compliance with regulatory requirements.
The incumbent will review Document Change Orders (DCOs) for compliance with regulatory requirements and review/approve labeling: device labels, brochures, technique guides, bulletins, updates, etc. They will review promotional materials for compliance with regulatory clearance/approval, review presentation materials for Synthes-sponsored events for compliance, particularly in respect to claims, intended use and indications, and prepare export certificates and medical device listings. They will obtain and maintain Certificates to Foreign Governments and Certificates for Export, regulatory records retention (update electronic regulatory archives with all cleared and/or approved regulatory submissions), and maintain regulatory database (JDE) - ongoing update of database with regulatory information. They will keep current in regard to US and Canadian regulations, guidance documents, Federal Register notices, and competitor news, provide assistance and guidance to junior staff members, participate in cross-functional projects teams, as assigned, and will participate in profession organization(s) e.g. RAPS, AAMI, ASTM, etc. They must know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times. They will diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer, and perform other duties as assigned.
Qualifications
A minimum of a Bachelors Degree is required. A minimum of 4 years of regulatory experience in the medical device and/or pharmaceutical industry OR an Advanced Degree and a minimum of 3 years of regulatory experience in the medical device and/or pharmaceutical industry is required. Solid knowledge of US FDA regulations and review processes are required. Practical experience in a medical device Regulatory Environment, preparing US submissions for Class II and/or III with a successful track record is preferred. Candidate must be flexible, cooperative, and team-oriented, have the ability to build strong relationships and work well with other departments, and possess excellent written and verbal communication skills. Candidate must be detail-oriented, while having the ability to handle multiple ongoing projects/tasks. Advanced computer skills, specifically MS Word and Adobe are required. This position will be located in West Chester, PA and requires up to 10% travel, including some light international.
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Primary Location:
North America-United States-Pennsylvania-West Chester
Organization:
Depuy Orthopaedics. Inc. (6029)
Job Function:
Regulatory Affairs
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