Senior Regulatory Affairs Specialist - MedTech Surgery

Johnson & Johnson • Cincinnati, OH

7d • Hybrid

About The Position

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.

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.

Nice To Haves

• 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.

Responsibilities

• 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.

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 period
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior