Senior Regulatory Affairs Specialist
DePuy Synthes Companies of Johnson & Johnson is recruiting for a Senior Regulatory Affairs Specialist 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.
The Senior Regulatory Affairs Specialist is responsible for regulatory activities to support new, modified and currently marketed medical devices in the DePuy Synthes line of products. This includes the preparation of regulatory documentation for submission to regulatory authorities (e.g., IDE, 510(k), PMA and European MDR) or internal regulatory assessment documentation. The Senior Regulatory Specialist is also responsible for the review and approval of all device labeling and product support information used in the promotion and educational activities of DePuy Synthes products for compliance to FDA regulations, European MDR requirements and company policies and procedures.
POSITION DUTIES & RESPONSIBILITIES:
- Ensures compliance with regulatory agency regulations and interpretations.
- Prepares responses to regulatory agencies’ questions and other correspondence.
- Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
- Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
- Provides solutions to a variety of problems of moderate scope and complexity.
- Researches, collects data, and responds to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information to associates and affiliates
- Prepares regulatory labeling requirements specifications for new and modified products, and reviews product labeling to ensure compliance
- Provides regulatory guidance to product development teams and responds to product information requests
- Provide Regulatory Affairs support during internal and external audits
- Assists in the development of best practices for Regulatory Affairs processes
- Represents Regulatory Affairs on cross-functional project teams
Functional and Technical Competencies:
Leverages scientific and technical understanding of regulated products within scope of responsibility to provide regulatory input to product lifecycle management and evaluate regulatory impact on products (for example, provides Regulatory input into product recall strategies).
Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives.
Consults with others to understand the benefits, risks, and J&J Credo-based impact associated with decision alternatives before making decisions.
Provides support to complex projects and makes timely and effective decisions based on available information to execute project deliverables. Makes decisions with guidance in ambiguous or unclear situations.
- Connect by encouraging and supporting internal collaboration across levels, creating effective solutions. Builds and leverages internal and external networks with colleagues, cross-functional partners, and industry contacts to identify opportunities and open communication channels
- Shape by challenging the status quo and adapting to change, taking advantage of opportunities to have a positive impact. Engages with local and/or regional regulatory agencies, industry groups, standards committees, political/government agencies, in order to influence external stakeholders and promote Regulatory perspectives
- Lead by leveraging diverse perspectives, backgrounds and talent to generate effective ideas or solutions
- Deliver by acting with speed, flexibility, accountability and appropriately managing priorities to deliver results for on-time clearances
Bachelor degree from accredited college or university in science, biomedical engineering, medical / scientific writing, public health administration
6+ years of regulatory affairs or related/equivalent experience, including relevant experience with 510(k) submissions and CE marking
RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society, desirable
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability
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Job posted: 2021-09-12