Senior Regulatory Affairs Specialist MedTech Surgery

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:

Professional

All Job Posting Locations:

Cincinnati Ohio United States of America

Job Description:

About Surgery

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Are you passionate about improving and expanding the possibilities of surgery Ready to join a team thats reimagining how we heal Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the worlds most prevalent conditions such as obesity cardiovascular disease and cancer. Patients are waiting.

Your unique talents will help patients on their journey to wellness. Learn more at are searching for the best talent for a Senior Regulatory Affairs Specialist to support our Torax Medical business. This role will work a Flex/Hybrid schedule and be based in the Cincinnati OH office. There is NO remote option and relocation assistance is not provided.

Purpose: The Senior Regulatory Affairs Specialist is an individual contributor that works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements for Torax Medical. The individual combines knowledge of scientific regulatory and business issues to ensure that products which are developed manufactured or distributed by J&J MedTech Surgery meet the required legislation the United States and rest of world. Through your engagement in this role you will help shape the life-saving field of heart recovery.

You will be responsible for:

• Prepare and submit regulatory documents including applications for product registrations amendments annual renewals to respective health authorities and Notified Bodies (e.g. US FDA TUV).
• Collaborate with regional regulatory partners as needed in preparing submissions for global expansion.
• Evaluate proposed changes for regulatory impact and perform any required regulatory submissions/amendments.
• Maintenance of licenses throughout product lifecycle.
• Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes in responsible jurisdictions .
• Provide regulatory support for internal and external audits (e.g. MDSAP).
• Monitor and anticipate changes in regulations in responsible jurisdictions.
• Prepare regulatory documents (e.g. CFG) to support global expansions or tenders.
• Have Regulatory Affairs experience in the medical device industry with a track record of successful US and OUS submissions supporting commercial medical devices.
• Be passionate about Regulatory Affairs impact in support of the research development clinical marketing and production of state-of-the-art Class II and class III medical devices.
• Be energized by joining a world-class company and regulatory team.
• Enjoy teamwork and thrive as a member of dynamic cross-functional teams.
• Build and maintain strong interpersonal relationships within and outside of the company.
• Exhibit leadership traits- positive forward looking accountable action-oriented delivering results.
• Be adaptable and thrive in a dynamic work environment where variety is the routine.
• Embrace change continuous learning and work skills improvement.
• Able to manage multiple competing priorities across several modalities and legal manufacturers.

Qualifications / Requirements:

• Minimum of a Bachelors Degree required Advanced degree is strongly preferred. Science or Engineering discipline highly desired.
• At least of 2 years of related professional Regulatory Affairs experience required (1 with Advanced Degree).
• Experience in reviews of engineering manufacturing marketing labeling and clinical documents for regulatory compliance.
• Ability to effectively manage multiple projects and priorities.
• Strong communication and regulatory writing skills.
• Strong problem solving skills interpersonal skills and effective team member.
• Results oriented. Ability to drive to completion in adherence to aggressive project schedules.
• Ability to comprehend principles of engineering physiology and medical device use.
• Experience with US Class II (510k) and Class III (PMA).
• Data analytics and project management experience preferred.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
• Travel up to 10%.

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 & 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 accommodationexternal applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

Preferred Skills:

Analytical Reasoning Business Behavior Business Writing Communication Confidentiality Data Reporting Detail-Oriented Legal Support Medicines and Device Development and Regulation Problem Solving Product Licensing Regulatory Affairs Management Regulatory Compliance Regulatory Development Regulatory Environment Risk Assessments Teamwork

The anticipated base pay range for this position is :

The base pay range for this position is $92000 to $148350.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance. Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire Employees are eligible for the following time off benefits: Vacation 120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year Holiday pay including Floating Holidays 13 days per calendar year Work Personal and Family Time - up to 40 hours per calendar year Parental Leave 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave 10 days Volunteer Leave 4 days Military Spouse Time-Off 80 hours Additional information can be found through the link below. Experience:

Senior IC