Job Description

About Freyr Inc.

Freyr Inc. is a global leader in regulatory solutions and services within the life sciences industry. Headquartered in Princeton, NJ, Freyr specializes in providing Regulatory Affairs, Pharmacovigilance, and Quality Assurance services. With a diverse team worldwide, we deliver efficient and compliant regulatory solutions to clients in the pharmaceutical, biotechnology, medical device, and consumer healthcare sectors.

Job Title: Lead, IVD, Precision Medicine Regulatory Affairs

Department: Regulatory Affairs

Location: Princeton NJ - US Remote

FUNCTION: Regulatory Affairs (IVD and Precision Medicine)

POSITION OVERVIEW:

As a team member in Precision Medicine Regulatory Affairs, you will support the implementation of Precision Med. Regulatory strategies and investigational device related submissions, in collaboration with Regulatory liaisons and stakeholders from other functional areas. You will ensure compliance with all applicable IVD regulations, primarily in, but not limited to, the EU (IVDR), UK, the US (FDA) and China. In addition, you will provide Diagnostics (Dx) Regulatory operational and PM support to establish streamlined internal business processes and fit-for-purpose QMS that will enable IVD submissions across all stages of clinical development. You will be functionally reporting to the Director, Global Regulatory Affairs in Precision Medicine.

EXAMPLE RESPONSIBILITIES:

• Maintains current understanding of global IVD regulations, assesses and communicates their impact on companion diagnostics (CDx) development & registration activities.
• Provides IVD regulatory input during drug clinical development to ensure compliance of diagnostics used in therapeutic trials with all applicable global and local regulatory requirements (such as US FDA and EU-IVDR), established practices, policies, and processes.
• Provide inputs on key development documents, such as SRDs, IDE applications (with FDA), device clinical performance study applications under IVDR, diagnostic study protocols & reports, IVDR Technical Files, PMAs and labels for companion diagnostic products.
• Contributes to internal Regulatory Precision Medicine process improvements (business process excellence), which have a significant impact on business.
• Drafts Regulatory SOPs and Work Instructions, as needed.
• Plans and implements approved quality improvement action items and related activities, in support of an integrated cross functional Medical Device QMS.
• Tracks Regulatory Precision Medicine initiatives and activities across different clinical programs, generates program-specific dashboards.

REQUIREMENTS:

Education & Experience

• PharmD/PhD with 3+ years’ relevant experience.
• MA/MS/MBA with 5+ years’ relevant experience.
• BA/BS with 8+ years’ relevant experience.
• Significant regulatory, quality, compliance, medical writing, or related experience supporting in vitro diagnostic development and commercialization.
• Prior experience with IVD technologies (IHC, PCR, NGS, etc.) and the impact on outcomes and diagnostic results.
• Substantial experience with authoring SOPs and implementing processes.
• Prior experience with cross-functional projects and teams related to IVD development and clinical study.

Knowledge & other Requirements

• Thorough knowledge of international standards, systems, policies, and procedures that enable compliance with IVDR, adherence to Good Clinical Practices (GCP), and Medical Device QMS operations.
• Understanding of global policy, laws, regulations, and guidelines as applied to diagnostic development and various types of IVD submissions.
• Thorough knowledge of the CDx co-development process, including key functions involved in various stages of development.
• Strong organizational, project management and process improvement skills (experience with Smartsheet and other PM tools is a plus)
• Excellent verbal, written, & interpersonal communication skills, corporate presentation skills

Why Join Us?

Flexibility: Enjoy remote work with opportunities for client travel and industry engagement.

Growth Opportunity : Be part of a fast-growing, global organization at the forefront of life sciences regulatory consulting.

Innovation: Work with cross-functional teams delivering cutting-edge solutions to industry leaders.

Equal Opportunity Employer:

Freyr Inc. is an equal opportunity employer and values diversity at our company. All qualified applicants will receive consideration for employment without regard to race, religion, gender, sexual orientation, national origin, or disability status.

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