Regulatory Affairs Manager / Affaires réglementaires to manage the quality and regulatory affair activities for medical devices and cosmetic products.
Publication date:21 November 2022
Workload:70 – 80%
Place of work:Galilée 6, 1401 Yverdon-les-Bains
About our company
Suisselle SA is a young scale-up based in the technology parc of Yverdon-les-Bains, Y-Parc and active in the R&D, manufacturing and commercialization of innovative aesthetic medicine products.
Suisselle is seeking a highly motivated candidate to join our team and contribute directly to the development and growth of the company.
We are looking for :
Regulatory Affairs Manager
The RA Manager will be responsible for the following tasks (non-exhaustive list):
- To ensure that Suisselle’s products (medical devices and cosmetics products) meet all necessary regulatory requirements;
- Administration and maintenance of all regulatory certifications, including but not limited to ISO 13485, 9001, MDR (EU) 2017/745,and others, and act as the contact person for regulatory inspections / audits ;
- To ensure the product registration activities for commercial medical devices:
Prepare and submit applications for marketing authorisations/registrations, advice to concerned development departments regarding the quality, analytical methods, pre-clinical and clinical development to ensure acceptance of the data worldwide;
Coordinate change control procedures (collection of regulatory assessments worldwide) and their international implementation;
Organize regulatory projects, communicate with third parties concerning all regulatory issues
Coordinate the development of regulatory strategies, participate in project teams and act as the contact person with regards to regulatory requirements.
The RA Manager will perform its activities, working in closed collaboration with the Sales, Marketing, R&D, Production and Supply Chain departments.
The Successful Applicant
- Completed natural science degree, preferably in engineering, chemistry, biology or equivalent ;
- At least 5 years of professional experience in the field of quality and regulation for medical devices ;
- Experience in ISO 13485, ISO 9001, MDR (EU) 2017/745, ISO22716, Regulation (EU) 1223/2009 (cosmetic products)
- Strong organizational, presentation and management skills;
- Strategic and analytical thinking ;
- Highly Structured way of working ;
- Strong communication personality with assertiveness ;
- Extensive experience in project management as well as very good knowledge of MS Office ;
- Very good written and spoken English and French.
No recruitment agencies please