Regulatory Affairs & Compliance Manager Digital (m/f)

Our client is headquartered in Basel, Switzerland. As a global leader in implant, restorative and regenerative dentistry our client shares your passion for quality and the desire to achieve the best restorative outcomes. Our client offers a broad range of products and solutions for both conventional treatment and digital workflows including guided surgery, intra-oral scanning and CAD/CAM restorations.

REGULATORY AFFAIRS & COMPLIANCE MANAGER DIGITAL (M/F)
BASEL

YOUR TASKS

  • Participate on assigned project (MDR implementation) and product development teams by representing and reinforcing Design Control, Quality Assurance and Regulatory Affairs requirements
  • Work in a multidisciplinary group for Technical File adaption according to MDR 2017/745
  • Ensure that the technical documentation supporting the CE mark complies with MDD 93/42/EEC
  • Create and maintain Technical Files/Design Dossiers
  • Create US and Canadian submission dossiers
  • Support the International Regulatory Affairs Team in preparation of international Submissions
  • Interaction with authorities, notified bodies and any other approving bodies that will be relevant
  • Assessment of potential risks and the classification of the medical device in accordance with MDD and MDR
  • Support and consultation of the Departments in regard of interpretation of regulatory rules/laws/guidelines
  • Identify and communicate potential risks in submission and anticipate regulatory responses through scenario planning

YOUR PROFILE

  • BSc or MSc degree in a technical or natural scientific field
  • At least two years professional experience in Regulatory Affairs and/or Quality Management
  • Knowledge about the standards and directives for Medical Devices such as ISO 13485, ISO 14971, MDD 93/42/EEC and MDR 2017/745
  • Experience from Audits would be a plus
  • Fluency in English (in writing and speaking), further knowledge of additional languages e.g. German would be an asset
  • Customer-driven, solution-focused, systems-oriented and emotionally intelligent personality
  • Advanced knowledge of excel and data analysis would be a plus

YOUR BENEFITS

  • The costs of commuting with public transportation to work in Basel and region will be covered
  • You will have a daily supply of fresh bio fruits, vegetables, salads, sushi, muffins etc.
  • You will be provided with individual coaching and training
  • You have the possibility to work in Asia and South-America after 2-3 years
  • Lose hierarchies, the CEO knows everyone by name and welcomes you personally on your first day at work