(V001) Senior Regulatory Affairs Specialist (Orthopedics) - Medical Device Business Services, Inc.

Medical Device Business Services, part of Johnson & Johnson MedTech, is currently recruiting for a Senior Regulatory Affairs Specialist to support our Orthopedics business. This role will work a Flex/Hybrid schedule and must be based within a commutable distance of Raynham, MA or Warsaw, IN. There is NO remote option.

About Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Position Overview

The Senior Regulatory Affairs Specialist is responsible for regulatory activities to support new, modified and currently marketed medical devices in the DePuy Joint Reconstruction portfolio. This includes the preparation of regulatory documentation for submission to regulatory authorities (e.g., IDE, 510(k), PMA, Design Dossiers, and Technical Documentation) or internal regulatory assessment documentation. The Regulatory Project Leader 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 global regulations and company policies and procedures. In conjunction with other functions, they support post market and provide lead external and internal audits.

Primary Responsibilities:

1. Prepares regulatory documentation for DePuy devices, including IDE, 510(k), PMA, Technical Files, Design Dossier, and Technical Documentation files for submission to regional Health authorities per FDA, MDD and MDR requirements.
2. Resolves regulatory issues and questions from regulatory agencies during the pre-market product development phase.
3. Provides support in preparation, writing and submission of global registration activities (Japan, China, Australia, NZ) requirements for New Product Development projects.
4. Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.
5. Reviews and approves changes with Product Lifecycle Management System to devices, design, packaging and labeling for Notified Body, FDA, and Global impact.
6. Reviews product labeling and product support information for currently marketed products to ensure that product information and claims are consistent with premarket clearances and approvals and in compliance with relevant regulations and guidance.
7. Maintains current knowledge to ensure compliance to the applicable regulatory and corporate standards/requirements (FDA Quality System Regulations, European Quality Standards and presiding Medical Device Regulation, ISO, previous MDD, etc.).
8. Performs other duties as assigned.

Qualifications Minimum Requirements:

1. Minimum of a Bachelor's Degree required; Advanced Degree strongly preferred.
2. Minimum 3+ years related Regulatory Affairs experience, preferably within Medical Devices (2+ years with Advanced Degree).
3. US FDA or Notified Body Submission experience strongly preferred.
4. Knowledge or Familiarity of U.S. FDA and EU Medical Device Regulations MDR (and previous MDD) and presiding guidance’s and standards highly desired.
5. Knowledge of orthopedic implants preferred.
6. Familiarity with electronic submission preparation a plus.
7. Excellent written and oral communication skills.
8. Ability to handle multiple tasks, self-motivate and be detail oriented.

The anticipated base pay range for this position is $ to $ based on experience. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.

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.