Manager Regulatory Affairs - Combination Products

Leads combination product regulatory activities, including device development activities, protocol reviews, leading/managing Health Authority (HA) correspondence and submissions. This role includes supervising various outside contractors, supporting project teams and development partners and leading Health Authority activities.

In this role, a typical day might include the following:

• Provide regulatory interpretation, position and strategy for combination products and devices requirements
• Support device development activities from a regulatory standpoint during early phase, development, submissions and post market requirements
• Support development of design control documentation and quality systems for combination products
• Support combination products regulatory submissions, including acquiring HA feedback and submitting IND, CTA, BLA applications and MAA filings.

This role might be for you if:

You have expertise with implementing device regulations

Strong Technical writing and oral communication skills.

Experience with Health Authorities, V&V protocols and test reports.

We seek previous experience with device regulatory requirements and development processes for combination products

Experience writing technical documents like test reports, technical memos, input requirements documents, human factors protocols, etc.

Experience preparing information for 51Ok, IDE, IP and PMA submissions is a plus

Human Factors and Pharmaceutical experience

Regulatory submissions experience

Understanding of global regulatory requirements for device and combination products

We require Bachelors in Science, Applied Science, Engineering, Industrial Design, or similar and 10+ years' experience, Master's Degree with 8+ or PhD with 3+ years working with medical, commercial or industrial products from pharmaceutical, regulatory, design, testing, validation, ergonomics and human factor perspective. Ideal candidate will have a combination of regulatory, pharmaceutical, device design, testing, human factors and usability expertise in regulated environment.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.