Our client, a dynamic medical device company based in Switzerland, specialized in implants and surgical, is looking for a Senior Regulatory Affairs professional on a permanent basis.
The ideal candidate should be a highly motivated individual with at least 8+ years of experience regulatory affairs in the fields of medical technology or pharmaceuticals.
- Ensure that regulatory guidelines for the approval of devices are met during the product development process;
- Support and consulting for research & development and brand management in the interpretation of regulatory requirements throughout the entire lifecycle of the products and ensuring that the technical documentation of the products complies with the respective requirements for medical devices;
- Communication of new regulatory approval requirements to research & development as well as brand management and support in the implementation thereof;
- Participation in interdisciplinary product development teams;
- Assessment of products with regard to their risk potential;
- Responsible for the regulatory content of product-related details and its release;
- Conducting conformity assessment procedures for the products and initiating the preparation of the declaration of conformity;
- Support of international product registration;
- Support in preparation and execution of audits;
- Support in continuing improvement of quality procedures and regulatory processes.
Qualifications and Experience:
- BSc/MSc/ studies in engineering/studies in the field of medicine;
- 8+ years of experience in Medical Devices or Diagnostics or Pharma/Biotech;
- Experience in quality management and /or product development is an advantage;
- TÜV certified Regulatory Manager or equivalent education;
- Knowledge of MDD 93/42/EEC (product classification, definition of applicable standards, conformity assessment procedures);
- Proficiency in IT Tools: MS Office Software (Word, Outlook, Excel, PowerPoint); ERP/SAP;
- Excellent written and oral communication skills in English & German desirable;
- Ability to multitask in interdisciplinary environment;
- Relevant working/residency permit or Swiss/EU-Citizenship required.