Senior Regulatory Affairs Program Lead - Electrophysiology

Senior Regulatory Affairs Program Lead

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 Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness.

We are searching for the best talent for a Senior Regulatory Affairs Program Lead. This is a remote role available in all states within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

Purpose : Develop and implement regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations and standards.

You will be responsible for :

• Ensuring compliance with global regulations and regulating agencies.
• Instilling and driving a regulatory culture.
• Representing the regulatory function on project teams.
• Coaching project teams on input for product labeling, claims support, promotional and scientific materials.
• Working collaboratively with cross-functional teams.
• Developing IDE, 510K, and / or PMA submissions.
• Generating documentation to be submitted to worldwide governmental regulatory agencies.
• Conducting submission negotiations with regulatory authorities.
• Working with others as a team player.
• Maintaining proficiency on regulatory requirements.
• Providing continuing regulatory education.
• Performing copy review for internal and external documentation.
• Providing regulatory support for internal and external regulatory agency audits.
• Coaching junior colleagues in techniques, processes, and responsibilities.
• Communicating business related issues or opportunities.
• Ensuring compliance with all Federal, State, local and Company regulations.
• Performing other duties assigned as needed.

Qualifications / Requirements :

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.

The anticipated base pay range for this position is $105,000 to $169,050. 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. Employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). 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.