Senior Consultant – Regulatory

We’re looking for an experienced Senior Regulatory Consultant to join our team. The ideal candidate will have deep expertise in regulatory affairs for medical devices and digital health, with a focus on FDA and EU MDR, and experience managing submissions for Software as a Medical Device (SaMD).

Responsibilities:

• Act as a regulatory expert on FDA, MDR, and other frameworks
• Develop and execute regulatory strategies for digital health products
• Guide clients through regulatory submissions and communications with authorities
• Prepare regulatory documentation (e.g., Technical Files, Risk Management Files)

Qualifications:

• 7+ years in Regulatory Affairs, specializing in medical devices and digital health
• Bachelor’s degree required; Master’s preferred
• Expertise in FDA and EU MDR regulations

Preferred Experience:

• SaMD and AI/ML regulatory frameworks
• Digital health product development
• QMS auditing and strategic consulting

For more information, do get in touch with Patrcia.Sousa@lifescirecruitment.com

At Life Sciences Recruitment Ltd (LSR), we are a Global Life Science recruitment firm that specialises in partnering with start-ups and fast-growing biotech and pharmaceutical organisations.

Founded in 2021, we recognised the need for a company with a search firm’s insights, knowledge and credibility but offering a contingent service.

As one of the most competitive and fast-paced industries globally, succeeding and growing in the life sciences business requires a combination of creativity, technical expertise, and business savvy. At LSR, to find the best talent for your organisation, our dynamic recruitment consultants tap into our unparalleled network of contacts and apply a quality-based approach to a contingent search model tailored to your needs. We provide the most sought-after candidates to fit your requirements, from temporary placement to Fortune 500 companies!

LSR is a privately owned and independent recruitment company focused on the Life Sciences industry. We are a subsidiary of Morgan Prestwich (MP), Europe’s leading boutique Life Sciences executive search and advisory firm.

Contact us today to learn more about our recruitment services!