Regulatory Affairs Specialist (Medical Devices & Digital Health)
Remote · Full Time
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- Experience
- 5+ yrs
- Salary
- —
- Openings
- 1
- Posted
- 2 weeks ago
- Work mode
- Work from home
- Resume
- Required to apply
Job description
About SISU Health
SISU Health is dedicated to enhancing preventative healthcare accessibility and efficacy through innovative solutions. Their health stations offer self-service health checks in diverse settings such as workplaces, pharmacies, and community spaces, enabling individuals to quickly gain health insights.
Their platform integrates medical devices with digital health technology to provide personalized health insights and referral pathways, targeting early identification of risks related to hypertension, cardiovascular issues, and diabetes.
Role Summary
This opportunity is for an experienced Regulatory Affairs Specialist to lead and implement regulatory strategies for the SISU Health connected health platform and its upcoming products. The position is a 12-month fixed-term contract, available full or part-time, and fully remote within the UK.
Key Responsibilities
- Manage new product registrations for Class I and Class IIa devices.
- Prepare, review, and maintain technical documentation and regulatory submissions.
- Evaluate the regulatory impact of new product features and design modifications.
- Engage in ISO13485 Quality Management System activities and support external audits.
- Offer practical regulatory guidance, keep abreast of regulatory changes, and address compliance queries.
Candidate Profile
- Possesses over five years of Regulatory Affairs experience in medical devices or digital health sectors.
- Has hands-on knowledge of MDR, MHRA regulations, especially regarding Class I and IIa software-enabled or connected medical devices.
- Experienced with ISO13485 standards.
- Skilled in drafting and reviewing technical documentation and regulatory submissions with confidence.
- Independent and decisive worker, thriving in fast-scaling environments.
- Problem solver who prefers pragmatic and balanced approaches.
- Effective collaborator who works closely with various business teams.
Why Join SISU Health
Joining SISU Health means becoming part of a blossoming health technology company committed to impacting thousands of lives annually. This role offers a unique chance to merge regulatory expertise with innovation, teamwork, and tangible impact.