Regulatory Strategy Lead / Senior Consultant - SaMD/AI Focus
Location: Fully Remote (Applicants must be residing in UK or Ireland and have right to work)
Imagine starting your day from the comfort of your home office, fully remote yet fully connected. You log into a virtual meeting with a dynamic start-up, eager to bring their innovative SaMD product to market.
Later, you’re reviewing technical documentation for an SME preparing their AI-powered diagnostic tool for a critical 510(k) submission. Your engineering background enables you to guide their team through early-stage design considerations, ensuring their product is not only compliant but also robust and market-ready.
Your afternoon might involve advising another client on post-market surveillance strategies, leveraging your knowledge of clinical evaluation and vigilance to ensure continued global market access.
This role is ideal for experienced Regulatory Specialists, Managers, or Heads/Directors seeking a permanent position where they can apply their technical expertise and regulatory acumen. You’ll work with a variety of innovative SaMD and digital health companies, guiding regulatory strategies across projects at various stages of development.
What makes this role stand out?
* Diverse Projects: Engage with cutting-edge technologies and guide organisations through complex regulatory pathways.
* Collaborative Team: Work with a supportive team of 11 experts passionate about MedTech innovation.
* Career Growth: Join a consultancy with a strong track record of training and promoting from within.
* Flexibility: Enjoy the benefits of a fully remote position.
Typical responsibilities:
* Prepare technical documentation and design dossiers.
* Lead regulatory submissions, including EUMDR, EU IVDR, US FDA 510(k)s, PMAs, IDEs, and global approvals.
* Solve regulatory challenges on classification, technical files, and validation processes.
* Advise on or conduct design and product risk management activities.
* Prepare, review, or update Clinical Evaluation Reports (CERs).
* Support post-market surveillance and ensure compliance with global regulatory requirements.
What we’re looking for:
* Expertise in regulatory affairs with a focus on SaMD/AI.
* Proven experience navigating MDR and FDA pathways.
* A background in engineering or the ability to support early-stage product development.
* Exceptional communication skills with a client-focused approach.
* A solutions-oriented, commercially minded mindset.
About the Company
Founded in 2012, IMED Consultancy has built a strong reputation for delivering regulatory expertise to a loyal and diverse client base. Led by a hands-on CEO passionate about MedTech innovation, the company values knowledge-sharing and collaboration, with a team dedicated to driving client success.
Why Join?
* Work on groundbreaking projects at the forefront of digital health.
* Collaborate with innovative start-ups and growing SMEs.
* Enjoy a flexible, fully remote role.
* Benefit from career growth opportunities in a company that promotes from within.
* Be part of a supportive, collaborative team environment.
If you’re looking for variety, flexibility, and the chance to make an impact in a rapidly evolving field, we’d love to hear from you.