Werfen North America · 8 hours ago
Principal, Regulatory Affairs
Norcross, GA
Full-time
Hybrid
Lead/Staff
8+ years expWerfen North America is seeking a Principal in Regulatory Affairs to manage pre-market regulatory activities ensuring compliance with US FDA, Health Canada, and EU IVD Regulations. This role involves preparing regulatory submissions, reviewing product labeling, and advising on regulatory strategies throughout the registration process.
Health CareManufacturing
Responsibilities
Participates as the regulatory design team member for new and significant changes to IL-labeled product, providing early input on analytical and clinical test requirements, acceptance criteria and regulatory submission strategy
Develops the global regulatory plan for inclusion in the design file, advising the Company on product classifications and registration path in key markets based on the commercial plan
Performs labeling reviews and Change Order (CO) reviews/signatures for new product and significant product modifications
Prepares FDA 510(k), Health Canada license and EU Notified Body submissions for new products and significant modifications, coordinating deliverables with R&D and Marketing, authoring summary analytical and clinical reports, interfacing with Regulatory agency/Notified Body and advising on strategies and requirements throughout the registration process
Reviews and approves commercial materials for compliance/consistency with registrations, including by not limited to brochures, presentations and training materials
Other regulatory activities as needed to support new product launches and significant product modifications
Qualification
Required
Requires a Bachelor degree, preferably in regulatory or science related areas
Minimum of 8-years' regulatory experience in the medical device industry (in-vitro diagnostics a plus) or equivalent experience
Experience in the preparation of regulatory submissions to US FDA, Health Canada and/or EU Notified Body with in the past 8 years
Knowledge of FDA 21 CFR 820, Health Canada Medical Device Regulatory, MDSAP Companion Document, with some exposure to either EU MDR or EU IVDR
Effective verbal and written communication in individual and group settings
Ability to prioritize and balance work load, with minimal supervision and in a fast pace environment
Language fluency: English essential
Company
Werfen North America
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.
Founded in 1959Bedford, Massachusetts, USA
1001-5000 employees
H1B Sponsorship
Werfen North America has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (12)
2023 (10)
2022 (2)
2021 (11)
2020 (8)
Funding
Current Stage
Late StageLeadership Team
Giovanni Russi
Chief Operating Officer
Dominique J.
Human Resources Business Partner
Recent News
2025-07-19
2025-05-17
2025-04-04
Company data provided by crunchbase