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

6029-MEDICAL DEVICE BUSINESS SERVICES Legal Entity

Job Location:

Palm Beach Gardens, FL - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

People Leader

All Job Posting Locations:

Oberdorf Basel-Country Switzerland Palm Beach Gardens Florida United States of America

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 Bachelors 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 Masters 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.

Johnson & Johnson is an 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 disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Experience:

Manager