Senior Regulatory Affairs Program Lead (Robotics & Digital Solutions) - MedTech Surgery, Inc

Johnson & Johnson; Santa Clara (CA); Hybrid; USD 104,000 - 167,000; Full time

Job summary

An established industry player in healthcare innovation is seeking a Senior Regulatory Affairs Program Lead. This pivotal role involves instilling a vibrant regulatory culture and collaborating with cross-functional teams to develop and implement regulatory strategies for new product clearances. You will prepare and submit regulatory information required for global market access, ensuring compliance with applicable regulations. This position offers a competitive salary range and a comprehensive benefits package, including medical, dental, and retirement plans. If you're ready to make a significant impact in the medical device sector, this opportunity is for you.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Performance Bonus

Vacation Time

Sick Leave

Holiday Pay

Qualifications

• 6+ years of Regulatory Affairs experience in Medical Devices.
• Strong communication and analytical skills are essential.

Responsibilities

• Develop and implement regulatory strategies for product clearances.
• Prepare and submit regulatory information for global market access.

Skills

Regulatory Affairs

Communication Skills

Analytical Skills

Problem-Solving

Project Management

Education

Bachelor's Degree

Advanced Degree

Job description

Job Description - Senior Regulatory Affairs Program Lead (Robotics & Digital Solutions) - MedTech Surgery, Inc. (2506235223W)

Position Overview

Robotics & Digital Solutions, part of the Johnson & Johnson Medtech Surgery, is recruiting for a Senior Regulatory Affairs Program Lead. The preferred location for this role is Cincinnati, OH; however, candidates located in Santa Clara, CA or Raritan, NJ will also be considered. This role will work a Flex/Hybrid schedule with 3 days per week on-site. There is NO remote option. Relocation assistance to Cincinnati, OH is available to qualified candidates.

About Johnson & Johnson

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. 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.

Key Responsibilities:

1. Instills and drives a vibrant regulatory culture, working among cross-functional groups as a teammate and collaborator.
2. Applies strategic regulatory thinking along with technical expertise to develop and implement regulatory strategies for new product clearances and approvals.
3. Prepares and submits regulatory information required to obtain global market access, including preparation, writing, and filing of FDA submissions (e.g., Q-submissions, IDEs, De Novo, 510(k)s) and global health authorities’ submissions technical documents.
4. Serves as a Regulatory Affairs subject matter expert on new product development and engineering design control teams, conducting reviews and providing expert regulatory feedback.
5. Proactively identify issues, effectively communicate timelines for project completion, and address complex issues that may impact registration status.
6. Conduct regulatory evaluation of changes to devices in accordance with requirements of commercial/operating geography and generate the required regulatory submission.
7. Guides conformance with applicable regulations and guidance documents in product development.
8. Assists in the development of Regulatory Affairs processes.

Compensation and Benefits

The anticipated base pay range for this position is $104,000 to $166,750. The Company maintains highly competitive, performance-based compensation programs. This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, and group legal insurance. Employees may also be eligible for the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Time Off Benefits:

• Vacation – up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year
• Holiday pay – up to 13 days per calendar year

Qualifications

Required Qualifications:

1. Minimum of a Bachelor's Degree required; Advanced Degree highly desired.
2. Minimum of 6+ years of related Regulatory Affairs experience within Medical Device required.
3. Experience with medical device regulatory new product submissions required.
4. Demonstrated track record of developing and driving implementation of regulatory strategies.
5. Good communication skills for effective collaboration with cross-functional partners.
6. Excellent verbal and written communication skills; strong attention to detail.
7. Advanced analytical and problem-solving skills.
8. High organization skills with the ability to lead multiple projects/tasks simultaneously.
9. This position will require up to 25% travel.

Preferred Qualifications:

1. Previous experience with health authority meetings/interactions.
2. Experience with medical device software guidance, IEC 60601, sterilization, biocompatibility, and reprocessing requirements.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.