Sr. Manager Regulatory Affairs

Job Description

The Senior Manager, Regulatory Affairs will own and drive all regulatory activities across the product lifecycle for our regulated products portfolio. The role will ensure compliance with U.S. regulations (e.g., 21 CFR Part 820) and global standards (e.g., ISO 13485, ISO 14971), support future expansion into international markets and higher classification devices, and serve as a strategic regulatory partner to senior leadership. This role is critical to the company’s next phase of growth and will lead a significant overhaul of regulatory processes, ensuring the organization is prepared for increased regulatory scrutiny, expanded product claims, and future global market access.

This individual will operate in a lean, evolving environment, where ambiguity is common and ethical decision-making is paramount. The successful candidate will be hands-on, pragmatic, and capable of building structure where little currently exists, while serving as a strategic regulatory partner to senior leadership.

This role is an individual contributor with the opportunity to grow into people leadership.

Top Priorities

• Regulatory remediation and reclassification efforts across a large portfolio (~2,000 products), supporting the transition from Class I to Class II

• End-to-end regulatory impact assessments, including labeling, claims, and submission strategy  Health hazard evaluations  Risk analysis  MDR (medical device reporting)

• Establishing foundational regulatory processes to support scale, audits, and future submissions

$140,000 to $150,000. - Exact compensation may vary based on several factors, including skills, experience, and education.

Skills and Requirements

• Bachelor’s degree in a scientific, engineering, regulatory, or related field (advanced degree preferred)

• 5+ years of Regulatory Affairs experience in the medical device industry

• Strong experience with FDA Class I devices, with demonstrated exposure or readiness for Class II environments

• Deep working knowledge of: o FDA regulations (21 CFR Part 820) o ISO 13485 and ISO 14971

• Experience interacting directly with regulatory authorities

• High ethical standards and sound judgment when operating in ambiguous or evolving regulatory situations

• Proven ability to build processes from the ground up in a growing organization

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].