Job details

Regulatory Affairs & Compliance Manager Digital (m/f)

Release Date

20. Dec 2017

Place of work

Basel - Switzerland

Functional area

Research + Development

Job Type

Full Time

Career Level

Manager without direct reports

Employment Type

Permanent

About us

We are looking for you as our new Regulatory Affairs & Compliance Manager Digital (m/f)

In this role you will responsible for the overall registration strategies, coordination, implementation, execution control and completion of product registration, assuring compliance with regulatory requirements. The position is based in Basel, Switzerland.

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
  • Detailed 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

Interested?

  • Become part of a creative, inspired and engaged team on a mission: #WeRockDentistry
  • Bring your ideas to life – create your footprint in the dental industry
  • You can expect an informal, hand-on working environment with opportunities to grow
  • Remarks

    Florian Rupp, HR Partner, is your first contact for further questions you might have. Please apply via our online application system or send your application via E-Mail to job.ch@straumann.com.

    For this position, we are not asking for profiles of HR Consultancies and Recruiting Agents. Please respect this.


    Contact Information

    Send your application to

    Institut Straumann AG
    Peter Merian-Weg 12
    4002 Basel
    Switzerland
    +41 61 965 11 11
    http://www.straumann.com
    job.ch@straumann.com