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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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, we’re 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 that’s 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 world’s 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 https://www.jnj.com/medtech.

We are searching for the best talent for a Senior Regulatory Affairs Specialist to support our active capital, energy-based 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 MedTech Surgery. The individual combines knowledge of scientific, regulatory and business issues to ensure that products meet the required legislation the United States and  global health authorities. Through your engagement in this role, you will help shape the surgical field.

You will be responsible for:

• Prepare and submit regulatory documents, including applications for new product registrations and maintenance of existing registrations, to US FDA  and EU Notified Bodies).
• Collaborate with global regulatory partners  to drive innovation and prepare global regulatory submissions.
• Maintain device registrations and licenses throughout product lifecycle.  Support product lifecycle. Evaluate proposed device changes for regulatory requirements and perform required regulatory submissions.  Assist in the development of multi-country regulatory strategy.
• Monitor changes in regulations.  Maintain and update strategy based upon regulatory changes in responsible jurisdictions.
• Provide regulatory support with teammates for internal and external audits (e.g. MDSAP).

Be passionate about Regulatory Affairs impact in research, development, clinical, marketing, and production of state-of-the-art medical devices.

• Able to manage multiple overlapping priorities across projects.

Qualifications / Requirements:

• Minimum of a Bachelor’s Degree required. Science or Engineering discipline highly desired.
• At least 4+ years of related professional Regulatory Affairs experience required (2+ with Advanced Degree).
• Ability to comprehend principles of engineering, physiology and medical device use.
• Experience in reviews of engineering, manufacturing, marketing, labeling and clinical documents for regulatory compliance.
• Exceptional self-education skills required, including proactive and comprehensive research of new and existing regulations, processes, and tools before requesting assistance.
• Strong verbal communication and regulatory/medical writing skills.
• Ability to effectively manage multiple projects and priorities.
• Exhibit leadership traits such as a positive, forward looking appraoch to problem-solving, and accountable, action-oriented, appraoch to deliver results.  Results oriented and ability to meet project schedules.
• Enjoy teamwork and thrive as a member of cross-functional teams.
• Be adaptable and thrive in a dynamic work environment where variety is the routine.
• Experience with US Class II device submissions .
• Experience with active medical devices, including software, cybersecurity and electromagnetic evaluation submissions, preferred.
• Regulatory Certification (such as RAC from the Regulatory Affairs Professionals Society) is a plus.
• 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 accommodation,  external applicants please contact us via https://www.jnj.com/contact-us/careers . 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 :

$92,000.00 - $148,350.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s 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 Colorado –48 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

Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave – 80 hours in a 52-week rolling period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits