90 applicants

Company

Regeneron · 5 days ago

Senior Manager, Regulatory Affairs IVD & CDx

United States

Full-time

Remote

Senior Level, Lead/Staff

$145K/yr - $237K/yr

8+ years exp

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BiopharmaBiotechnology

Comp. & Benefits

H1B Sponsor Likely

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Responsibilities

Contribute to the development and execution of IVD strategy in collaboration with key stakeholders and ensure that development timelines, regulatory pathways and commercialization plans are coordinated.

Represent RA IVD on clinical study teams, global regulatory study teams for assigned projects to ensure chances for regulatory submissions success are maximized.

Coordinate and manage reviews and revisions of regulatory submissions such as SRDs, IDEs, Performance Study Applications, 510(k)s and PMAs.

Oversee Health Authorities inquiries by distributing questions and coordinating with internal personnel for timely responses.

Stay abreast of changing regulations globally throughout the IVD lifecycle and develops solutions with members of RA IVD team to provide updates to the organization.

Build and maintain cooperative relationships as the point of contact with IVD providers and project teams.

Provide support to RA IVD department processes e.g. submission management and participates in internal RA IVD department initiative.

Customer focused with the ability to balance and manage multiple projects from multiple stakeholders to time and quality expectations.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

IVD Medical Device experienceRegulatory AffairsUS Medical Device submissionsInternational IVD regulationsCompanion diagnostic developmentProject management

Required

Bachelors degree in Life Sciences, Engineering or related technical field

Minimum 8-10 years’ pharmaceutical or diagnostics industry experience including 3+ years IVD/Medical Device Regulatory Affairs experience.

Experience authoring US Medical Device submissions (Q-sub, IDE, 510(k), PMA)

Familiarity with international IVD regulations (IVDR, PMDA, etc.) and global registrational processes for medical devices/IVDs

Excellent written and verbal communication skills

Experience with companion diagnostic development processes and regulatory filings

Benefits

Health and wellness programs

Fitness centers

Equity awards

Annual bonuses

Paid time off

Company

Regeneron

Glassdoor

3.9

Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.

Founded in 1988

Tarrytown, New York, USA

10,001+ employees

http://www.regeneron.com

H1B Sponsorship

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Trends of Total Sponsorships

2023 (104)

2022 (125)

2021 (116)

2020 (122)