Group Manager Regulatory Affairs 100% — Medartis
CHF 85'500 - 129'500
Medartis · Basel (BS)
- Location
- Basel
- Contract
- full-time
- Posted
- 39 days ago
SalaryCHF 85'500 - 129'500
Role overview
We are looking for a Group Manager Regulatory Affairs that is responsible for our global regulatory strategy, leading a team to comply with all
Ensures and advances efficient processes in a dynamic, international environment.
- We are looking for a Group Manager Regulatory Affairs that is responsible for our global regulatory strategy, leading a team to comply with all
- Ensures and advances efficient processes in a dynamic, international environment.
- Group Manager Regulatory Affairs 100% Your responsibilities Professional and disciplinary leadership and further development of a Regulatory Affairs Team Ensuring compliance with regulatory requirements
- Requirements for the development, production and market launch of medical devices Planning, coordination and control of regulatory activities and projects Technical support and consulting of the team and internal stakeholders (R&D, quality, production) in regulatory issues Responsibility for the planning, implementation and monitoring of national and international authorisation procedures (in particular CE marking, FDA) Ensuring quality, consistency and completeness of technical documentation Implementation and monitoring of CE conformity assessment procedures Heading and review of product files (DHF/DHR) and implementation of design reviews Assessment of product changes with regard to regulatory
- Degree in Life Sciences, Engineering, Pharmacy or equivalent
- Several years of experience in Regulatory Affairs in the medical technology or pharmaceutical industry
Main responsibilities
- Group Manager Regulatory Affairs 100% Your responsibilities Professional and disciplinary leadership and further development of a Regulatory Affairs Team Ensuring compliance with regulatory requirements
- Requirements for the development, production and market launch of medical devices Planning, coordination and control of regulatory activities and projects Technical support and consulting of the team and internal stakeholders (R&D, quality, production) in regulatory issues Responsibility for the planning, implementation and monitoring of national and international authorisation procedures (in particular CE marking, FDA) Ensuring quality, consistency and completeness of technical documentation Implementation and monitoring of CE conformity assessment procedures Heading and review of product files (DHF/DHR) and implementation of design reviews Assessment of product changes with regard to regulatory
- Requirements and reporting requirements Central contact person for authorities, designated bodies and external partners Working with audits and inspections as well as ensuring successful preparation and implementation Further development, harmonisation and implementation of regulatory processes, templates and tools Guidance and support in defining and implementing regulatory strategies
- Your qualifications Complete studies in life sciences, engineering, pharmacy or comparable Multiannual professional experience in Regulatory Affairs in medical technology or pharmaceutical industry Management experience and detectable experience in the technical management of projects/teams Knowledge of relevant regulatory authorities
Key requirements
- Degree in Life Sciences, Engineering, Pharmacy or equivalent
- Several years of experience in Regulatory Affairs in the medical technology or pharmaceutical industry
- Leadership experience and proven experience in leading projects/teams
- Sound knowledge of relevant regulatory requirements
- Experience in technical documentation and approval processes
- Very good German and English language skills in writing and speaking
- Proficient use of MS Office and ideally experience with PLM or document management systems
- Strong organizational skills and a high quality awareness
What the company offers
- For the benefit of the patient, Medartis has committed itself to providing surgeons and surgical personnel with the most innovative titanium implants and instruments and to provide the best service.
Application process
- We look forward to your complete online application.
- Medartis Human resources T +41 61 633 34 www.medartis.com
Company and context
- Requirements Experience in technical documentation and certification processes Very good knowledge of German and English in word and writing Safe handling of MS Office and ideally experience with PLM or document management systems Embossed organizational skills and a high quality awareness Communication strength and joy in cooperation with various stakeholders Structured, solution-oriented and independent mode of operation About Medartis Medartis is one of the leading manufacturers of medical products for osteosynthesis in the field of facial skull and extremities.
- We offer you responsible and varied activities with high quality requirements in a growing international company with advanced social benefits.
