Direct message the job poster from elemed
Associate Director | Contract Recruiter | MedTech | Digital Health | elemed Title: Senior RAQA Consultant – Software Medical Device
Location: Canton Vaud, Switzerland (Hybrid)
The Company
A forward-thinking MedTech organisation with an open culture and a dynamic team. You’ll take ownership of their innovative medical software device, driving submissions across European and US markets and ensuring compliance that directly impacts patient lives.
The Opportunity
As Senior RAQA Consultant, you’ll support the development and market launch of new software, collaborating closely with R&D and Marketing teams. You’ll exercise significant autonomy, co-lead critical gate reviews, and guide the technical documentation that underpins regulatory submissions. You will also support with an upcoming Audit later this year.
Key responsibilities:
Lead all Quality Assurance activities in compliance with IEC 62304
Participate in new product development from concept through to launch
Manage the software medical device lifecycle, including pre-market submissions and post-market surveillance
Support with audits taking place later this year
CAPA & NCs
Maintain product approvals and handle resubmissions as needed
Collaborate across multidisciplinary teams (R&D, Quality, Marketing, Management)
Proven experience with Software as a Medical Device (SaMD)
Strong knowledge of IEC 62304 and Quality Management Systems
Experience working in a lean start-up environments
FDA submission experience for software medical devices
Excellent communication and cross-functional collaboration skills
Interested? Send your CV directly to ahmed@elemed.eu or explore more roles at https://www.elemed.eu/vacancies/
Only candidates matching the criteria will be contacted; if you don’t hear back within 10 days, please consider your application unsuccessful.
Elemed is Europe’s leading MedTech technical recruiter, specialising in Quality, Regulatory, Clinical, and R&D roles. From Manager to VP level, we place experts who drive innovation and compliance in MedTech.
️ Elemed is an equal opportunity employer. We celebrate diversity and foster an inclusive environment for all candidates and contractors.
Seniority level Seniority level Mid-Senior level
Employment type Employment type Contract
Job function Job function Quality Assurance and Consulting
Industries Medical Equipment Manufacturing and Biotechnology Research
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