Responsibilities
- Lead the development and implementation of regulatory and quality assurance strategies, ensuring compliance with MDR, FDA, and other international medical device regulations.
- Coach and develop a small, hands-on Quality Assurance and Regulatory Affairs team, setting clear priorities, working directly alongside stakeholders, and building a lean, high-performance culture that adapts as Ada’s regulatory and quality needs evolve.
- Act as an internal SME (Subject Matter Expert) on regulatory requirements, industry trends, and compliance best practices, as required.
- Proactively advise management on regulatory changes and implications for Ada.
- Embed and automate Compliance in the SDLC: Partner with Engineering and Product to integrate regulatory checkpoints into agile workflows and automate QMS processes to reduce friction and increase delivery velocity.
- Oversee internal and external audits, including Notified Body audits and regulatory inspections.
- Serve as the primary liaison with Competent Authorities and Notified Bodies representing the company in all regulatory discussions to ensure compliance and strategic alignment.
- Oversee regulatory submissions, including Technical Documentation reviews, with a focus on Europe, the UK and USA. Act as the company’s PRRC (Person Responsible for Regulatory Compliance) under EU MDR (Article 15).
- Lead the global vigilance strategy, ensuring the identification, investigation and reporting of serious incidents and field safety corrective actions to the appropriate regulatory bodies (e.g., BfArM, FDA, MHRA).
- Act as the Management Representative under ISO 13485, reporting to senior management on quality and regulatory compliance performance, including Management Reviews.
- Ensure the technical documentation and the EU declaration of conformity for medical devices are drawn up and kept up-to-date.
Requirements
- At least four years of professional experience in regulatory affairs or quality management systems related to software as a medical device (SaMD).
- Demonstrated ability to design and scale a lean QMS appropriate for a Series B/C startup, with a track record of cutting waste, improving efficiency, and enabling the business to move quickly without compromising compliance.
- Strong expertise in EU MDR and in-depth knowledge of EN ISO 13485 is essential.
- Ability to negotiate with regulatory agencies, senior management, and other key stakeholders.
- Familiarity with global regulatory requirements.
- Experience in risk management for medical devices (ISO 14971) and proven audit experience.
- People Management experience with a proven record of managing, developing, guiding and scaling lean high-performance teams within a dynamic and collaborative environment.
- The ability to navigate ambiguity and drive solution-oriented discussions, proposing pragmatic, technically sound mitigations that enable product progress while meeting regulatory and safety requirements without over-engineering or unnecessary delay.
- An understanding of how software is built, deployed and monitored to effectively ensure its compliance i.e. you are comfortable discussing deployment pipelines, release automation and software testing frameworks.
Nice to Have
- Experience with US FDA in addition to knowledge of AI/ML regulation (e.g. EU AI Act, FDA guidance on AI/ML) would be highly advantageous.
- German language skills would be a bonus but are not essential.
Work Arrangement
Remote (Country)
Team
Team size: small. Structure: hands-on Quality Assurance and Regulatory Affairs team
Additional Information
- The role requires acting as the company’s PRRC (Person Responsible for Regulatory Compliance) under EU MDR (Article 15).
- The role requires acting as the Management Representative under ISO 13485.
- Remote work allowed only for candidates based in the UK or Germany.
- All applications must be submitted via online form; email applications are not accepted.
- All information will be kept confidential according to GDPR guidelines.
