Associate Director, Regulatory Affairs - In Vitro Diagnostics and Digital Health

Location: Remote - United States

Remote Type: Remote

Time Type: Full time

Job Description

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Device Regulatory Affairs Lead, Diagnostics Focus to join our Regulatory Affairs team, supporting our device and diagnostics programs in a remote work model. In this role, you will lead regulatory strategies for Companion Diagnostics, In Vitro Diagnostics, and Digital Health Technology while collaborating with cross-functional stakeholders and external partners. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

Location: Remote

Monday - Friday

Discover your role:

• Support device regulatory strategies across development, submissions, and commercialization.
• Coordinate regulatory pathways, development timelines, and commercialization plans.
• Lead health authority meetings covering In Vitro Diagnostics and Digital Health Technology.
• Present regulatory positions during agency interactions and discussions.
• Communicate critical program updates and regulatory risks to senior management.
• Build relationships with internal stakeholders and external device development partners.
• Monitor emerging technologies and global regulations impacting diagnostics and digital health.
• You thrive in a collaborative environment and help drive regulatory excellence.

This role requires:

• Bachelor’s degree in a scientific discipline.
• Advanced degree preferred.
• 8 years of pharmaceutical or medical device industry experience.
• 5+ years of Medical Device/In Vitro Diagnostics regulatory affairs experience.
• Experience with U.S. medical device submissions, including pre-submissions, Investigational Device Exemption (IDE), 510(k), and Premarket Approval (PMA).
• Experience with international device regulations, including Medical Device Regulation/In Vitro Diagnostic Regulation (MDR/IVDR) and PMDA requirements.
• Knowledge of Companion Diagnostics, In Vitro Diagnostics, and Digital Health Technology regulations.
• Strong project management skills.
• Strong written and verbal communications skills
• Ability to collaborate and influence

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

 

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter. 

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$179,600.00 - $293,000.00