Team Leader Regulatory Affairs
Vor 3 Tagen
Job Purpose
As Team Leader Regulatory & Compliance - Regenerative Solutions, you will be part of a small but highly motivated and very international team, dedicated to our regenerative product portfolio. With your regulatory and compliance knowledge, you will support product developments and life cycle activities for the regenerative portfolio in order to expand the availability of the products worldwide.
Main Tasks and Responsibilities
- Ensure that all products in scope are designed, manufactured and distributed in such a way that they are safe and effective for their intended use and meet applicable regulatory requirements, incl. change management
- Interact with authorities, Notified Bodies and other approving authorities and support during audits and inspections
- Guide and coach stakeholders in Regulatory and Compliance topics with particular focus on product safety and effectiveness/performance;
- Supervise/support the process of establishing project-related RA strategies and follow up on execution during the projects;
- Create/support and maintain Technical Files/Design Dossiers to complies with appropriate regulations
- Support the Regulatory Affairs teams in HQ and at subsidiaries/distributors in preparation of local submissions in line with agreed timelines and in compliance with relevant regulations;
- Monitor and communicate new regulatory requirements and support in implementing these.
Profile
Education
- Technical or scientific graduate degree (FH/Uni/ETH)
- Fluent (written and spoken) in English, strong commend in technical writing
- Any additional language is an asset
Experience
- 10 years professional experience in Regulatory Affairs and/or Quality Management
- Proven record of Regulatory Management level positions at various medical device companies and/or types of devices (risk classes)
- Detailed knowledge about the standards and norms for Medical Devices such as ISO 13485, EU 2017/745, FDA and Health Canada requirements.
- Experience with other jurisdictions (APAC; LATAM and DEMEA) would be beneficial
- Experience with Biomaterials and class lll products would be an asset
Personal Attributes & behaviors
- Pro-active and flexible individual with strong analytical skills, seeking to get things done and at the same time deal with a high variety of tasks
- Energetic, straight forward and performance-driven professional with strong execution abilities and customer focus;
- Effective, convincing and professional communication, both verbally and in writing;
- Capability to lead, guide and supervise a team as well as to cultivate a network of productive relationships in an international matrix environment;
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.
Employment Type: Full Time
Alternative Locations: Switzerland : Basel
Travel Percentage: 0 - 20%
Requisition ID: 12069
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