Sr. Program Lead, Regulatory Affairs
Johnson & Johnson · Irvine, CA
RegulatoryFull-time$109k–$175kCompany career page
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Role summary
Johnson & Johnson MedTech seeks a senior regulatory leader to develop and execute global regulatory strategies for medical device commercialization. The role involves managing submissions, ensuring compliance with international standards, and directing regulatory operations across device classifications.
What they're looking for
- Bachelor's degree in engineering, physical science, or biological science; Master's degree preferred
- 6+ years medical device industry experience with minimum 5 years in regulatory affairs
- Expert knowledge of FDA regulations, Quality System Regulation, and ISO 13485 standard
- Strong understanding of EU MDR requirements and new product development processes
- Demonstrated experience with IDE, 510(k), and PMA submissions for Class II and III devices
- Ability to influence cross-functional teams and negotiate with regulatory agencies
- Cardiovascular field experience and software-containing device regulatory knowledge preferred
What you'll be doing
- Develop and implement regulatory strategies and processes for timely global product commercialization
- Prepare and manage regulatory submissions including IDE, 510(k), and PMA documentation
- Conduct pre- and post-submission negotiations with FDA and international regulatory agencies
- Establish regulatory policies and standards; provide education to product development and marketing teams
- Ensure organizational compliance with applicable federal, state, local, and corporate regulations
Privacy & handoff
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