Regulatory Affairs Consultant (Wellness & GPSR 2023/988 & IVDR 2017/746)

About Generation Lab

Generation Lab is a leading company in DNA methylation-based longevity science. We were spun out of UC Berkeley, are backed by Accel, Samsung Next and others, and have raised $11M. We are building on an established US business to expand internationally, starting with Europe.

Our European service

BioNoise™ analyses DNA methylation patterns in a blood sample and provides a comparative, age-related informational estimate for general wellness, personal awareness and healthy-lifestyle purposes. It is available to adults aged 25 and over, is ordered through a participating provider, and the blood sample is collected by a trained healthcare professional or another person authorised under national law.

It is a wellness service, not a medical test. It does not diagnose, treat, prevent or monitor any disease or medical condition, and it does not provide medical advice.

The role

We are looking for a regulatory affairs professional to own regulatory for Europe, and over time for other international markets. You will be our primary source of truth on regulatory matters, taking over an established framework and documentation set from our current consultant with a structured handover.

The scope covers consumer wellness services under the General Product Safety Regulation (EU) 2023/988 today, and IVDR 2017/746 for future product lines. In Europe, our service launches first in a label-only configuration, where participating providers use their own collection materials, followed by collection-kit configurations assembled in the EU. You will carry both through market entry, one country at a time.

What you will own

• Documentation: author, own and maintain our regulatory and quality documentation under change control, from qualification rationale and technical documentation to quality procedures.
• Claims: review and approve all external material (marketing, provider-facing, labelling, website) against our claims-control framework before release.
• Market entry: assess national legislation country by country, including bioethics, biobank, consumer and marketing law and specimen transport, and turn each assessment into a clear go/no-go decision with an action list.
• Product safety: build and maintain GPSR technical documentation and product safety analysis for our collection kits, working with our EU kit assembler and responsible person.
• Localisation: manage translation of controlled material for each market, including review of the translations.
• Partners: manage the regulatory side of our laboratory and supply-chain relationships.
• Leadership: lead our weekly international compliance call with leadership, engineering, science and operations, and keep decisions moving.

Who you are

• 3+ years in regulatory affairs or quality within IVD or medtech, including authoring documentation, not only reviewing it.
• Working knowledge of IVDR 2017/746 (qualification, classification, technical documentation) and GPSR (EU) 2023/988 (manufacturer obligations, technical documentation, the Article 16 responsible person).
• Experience building and running quality procedures (ISO 13485 or ISO 9001).
• Able to research national legislation from primary sources and state conclusions together with their limits.
• Strong commercial judgement: you understand what the company needs, prioritise accordingly, and find the compliant route that moves fastest.
• Fast, hard-working and efficient, and comfortable owning outcomes in a small team.
• Clear, bottom-line-first communication for a non-regulatory audience.
• Fluent English, and based in the EU/EEA.

Strong plus

• Experience at an established regulatory consultancy, notified body or authorised representative.
• GDPR for special-category data (consent, processor terms, international transfers).
• Additional European languages.
• UK or Swiss regulatory experience.
• Startup experience, where processes are built rather than maintained.

How we work

• Remote, with a committed number of 16 weekly hours.
• Work planned in two-week cycles with clear deliverables and dates.
• A short written daily update, so progress is visible without extra meetings.

The engagement

A 2-month paid trial as an independent contractor, with the potential to become a full-time role.