Manager, Regulatory Affairs (Power Tools) - MedTech Orthopaedics, Inc.

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

Job Function: Regulatory Affairs Group

Job Sub Function: Regulatory Affairs

Job Category: People Leader

All Job Posting Locations: Oberdorf, Basel-Country, Switzerland; Zuchwil, Switzerland

We are searching for the best talent for Manager, Regulatory Affairs to support the Power Tools team within our Orthopaedics group. The preferred location for this role is Palm Beach Gardens, FL, but candidates in Zuchwil or Oberdorf, CH, will also be considered. This role will work a Flex / Hybrid schedule with 3 days per week on-site. There is NO remote option.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

• United States - Requisition Number: R-021721
• Switzerland - Requisition Number: R-023294

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Purpose

The Manager, Regulatory Affairs will lead, direct, and coordinate activities concerned with the submission and approval of new and/or modified products to government regulatory agencies. They will also lead, direct, and coordinate activities to ensure regulatory compliance, maintain market access, and meet regulatory agency commitments.

Responsibilities

• Lead, direct, and coordinate activities concerned with the submission and approval of products to government regulatory agencies.
• Provide mentorship to project team members regarding regulatory compliance issues.
• Lead all aspects of the preparation and maintenance of regulatory submissions and files.
• Establish accountability for the preparation of vital outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
• Ensure adherence to standard operating procedures and protocols for the rapid and timely approval of new products and regulatory support of marketed products.
• Interact with regulatory agency personnel to expedite approval of pending applications and to resolve regulatory matters.
• Collaborate with management to establish and prepare appropriate regulatory filings for product approvals.
• Work with team members and commercial partners on regulatory aspects of new product launches, submission of license applications, and assessment of product change impacts.
• Ensure organizational compliance with all applicable regulations and J&J policies.
• Assign projects or activities, provide day-to-day instructions, and suggest training activities to direct reports (if any).

Qualifications / Requirements

• Bachelor’s Degree required; Advanced Degree strongly preferred. Study in scientific, engineering, business, or legal discipline desired.
• At least 8+ years of relevant regulatory experience (6+ years with Master’s, 5+ years with PhD); Medical Device regulatory experience strongly preferred.
• Experience with US and European medical device regulatory processes required.
• Experience in preparing and submitting US regulatory files (510(k)s, PMAs) and European Technical Files and Design Dossiers.
• Demonstrated track record of developing and implementing global regulatory strategies aligned with business results.
• FTE Leadership experience is preferred.
• Ability to read, analyze, and interpret scientific, technical journals, financial reports, and legal documents.
• Ability to respond to inquiries or complaints from customers, regulatory agencies, or the business community.
• Effective presentation skills for top management and peers.