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Salary: USD 152,000 - 215,000 / annual
Element Biosciences is seeking an experienced Director of Regulatory Affairs to build and lead the company's regulatory function and establish regulatory strategies supporting expansion into regulated diagnostic markets. Reporting to the Chief Supply Chain Officer, this role serves as Element's senior regulatory advisor responsible for regulatory strategy across the company's in vitro diagnostic (IVD), next-generation sequencing (NGS), and regulated life science instrumentation portfolio.
The Director will establish and execute global regulatory strategies supporting product development, market authorization, commercial expansion, strategic diagnostic partnerships, and lifecycle management. This individual will work closely with executive leadership and Product, R&D, Clinical, Quality, Operations, Legal, and Commercial teams to ensure regulatory considerations are incorporated early into product and business decisions, balancing regulatory risk, business objectives, and speed to market.
Key responsibilities include: owning Element's global regulatory strategy for IVD, NGS, software, and regulated life science instrumentation products; serving as senior regulatory advisor to executive leadership; establishing regulatory strategies early in product development; leading regulatory strategy and execution for global market authorizations (US, EU, and other priority markets); leading significant interactions with regulatory authorities and external stakeholders; establishing regulatory strategy for diagnostic partnerships and collaborations; owning regulatory assessment and governance for product, software, manufacturing, and lifecycle changes; providing regulatory leadership for post-market reporting obligations; establishing regulatory governance and decision-making mechanisms; building and scaling the Regulatory Affairs function; and representing Regulatory Affairs in enterprise decision-making forums.
The role is onsite in San Diego with willingness to travel approximately 10% of the time.
REQUIREMENTS:
- Minimum bachelor's degree in life sciences, engineering, regulatory affairs, or related discipline; advanced degree or RAC (Regulatory Affairs Certification) preferred
- Typically 12+ years of progressively responsible medical device or IVD Regulatory Affairs experience, including substantial responsibility for regulated IVD product development, market authorization, and lifecycle management
- Demonstrated experience establishing regulatory strategy for complex diagnostic instruments, IVDs, molecular diagnostics, or similarly complex regulated products
- Experience leading regulatory programs across multiple major jurisdictions, including FDA and/or EU IVDR experience; experience with both strongly preferred
- Demonstrated ability to advise senior executives and influence product, technical, clinical, quality, and commercial decisions without relying on positional authority
- Experience building or scaling a Regulatory Affairs function, team, operating model, or infrastructure
- Deep working knowledge of ISO 13485, ISO 14971, post-market requirements, labeling, change control, and applicable medical device/IVD regulatory frameworks
- Exceptional regulatory judgment, including ability to assess and prioritize material regulatory and compliance risks and develop pragmatic, defensible solutions
- Proven track record of working well cross-functionally and collaboratively
- Self-directed, proactive, and embodies an enterprise mindset
