Job Description:

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 the regulatory compliance, maintain market access and regulatory agency commitments.

You will be responsible for:

• 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 protocol 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 application and to resolve regulatory matters.
• Collaborate with management personnel to establish and prepare appropriate regulatory filings for product approvals.
• Work with team members and commercial partners to be responsible for the regulatory aspects of new products launches, the submission of license applications, and the assessment of the impact product changes have on the status of regulatory licenses.
• Ensure organizational compliance with all applicable regulations and J&J policies.
• Assign projects or activities, provide day-to-day instructions, and suggested training activities to direct reports (if any).

Qualifications / Requirements:

• Minimum of Bachelor’s Degree required, Advanced Degree stongly preferred. Study in a 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) as well as European Technical Files and Design Dossiers
• Demonstrated track record of developing and implementing global regulatory strategies that align with business results
• FTE Leadership experience is preferred.
• Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents.
• Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
• Ability to effectively present information to top management and peers.

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