Regulatory Affairs & Compliance Manager


ETKON GMBH

Company Description

#ChangeMakers
Ready to make an impact?

We develop, manufacture and supply dental implants, clear aligners, instruments, CADCAM prosthetics and biomaterials for use in esthetic dentistry, tooth replacement and restoration solutions or to prevent tooth loss.

We empower our employees to perform and make an impact, to question the status quo, to drive change, to stay ahead of the competition. From the first Dental Implant in 1974 to the latest Digital Solution – we do things differently than others

We deliver innovation based on evidence. This is part of our employer culture as well as an exceptional team spirit that truly encourages diversity and a powerful “can-do” attitude.

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Within the Straumann Group, the world leader in the field of implant-supported and restorative prosthetics, etkon GmbH develops high-quality dental prostheses and manufactures them using state-of-the-art CADCAM technologies.

#WeChangeDentistry every day. Be part of it.

Job Description

The position is required by REGULATION (EU) 2017/745 (“MDR”) for manufacturers and their Authorized Representatives. The position holder will ensure that all products of manufacturers for which Etkon acts as Authorized Representative and that are intended to be distributed in the European Union are in compliance with the requirements of the MDR.

YOUR TASKS

  • Act as the Person Responsible for Regulatory Compliance (PRRC, as per MDR 2017/745 article 15) for Etkon
  • Define compliance strategy for the organization acting as Authorized Representative
  • Ensure the conformity of the devices is appropriately checked, in accordance with the quality management system and regulations under which the devices are manufactured, before a device is placed on the market
  • Ensure economic operators and products are registered in compliance with regulations and that the technical documentation and the EU declaration of conformity are drawn up and kept up-to date. Maintain and keep available the documentation at the disposal of competent authorities
  • Make sure the post-market surveillance obligations and reporting obligations are complied with in accordance with the regulations
  • Be the primary contact to the Competent Authorities and Notified Bodies of etkon GmbH, Institut Straumann AG and other Straumann Group manufacturers for correspondence and audits

Qualifications

  • Technical or natural scientific graduate degree (FH/Uni/ETH) and/or  minimum 4 years professional experience in Regulatory Affairs and/or Quality Management
  • Expert understanding of MDR and detailed knowledge about the standards and regulations for Medical Devices such as ISO13485, ISO 14971, MDD 93/42/EEC, Regulation (EU) 2017/745 (MDR)
  • Fluent (written and spoken) in English, strong command in technical writing
  • Ability to absorb and impart information and communicate effectively to as well as convincing others on a factual basis, both verbally and written
  • Experience in medical device development with a focus on software and electrical devices
  • A track record of success through appropriate technical skills, including product registration and definition of successful strategies for product registrations
  • Proven leadership abilities and a team-oriented perspective who finds the right balance between demand and support
  • Actively cultivates a network of productive relationships in an international matrix environment

Additional Information

What can you expect from us?

  • An agile and ambitious environment: We are #ChangeMakers.
  • Open, friendly colleagues who #collaborate and #support each other: We are #Players+Learners.
  • An employer who invests in our #inspiring corporate #culture.
  • The #opportunity to develop yourself as a person and in your #career. We #grow.
  • #Attractive workplaces at great locations – We are a #GlobalPlayer.
  • A good salary and many other cool #benefits.
  • To work for the No. 1 in #Dentistry and one of the leading #MedTech companies.

and many other things more!

What do people say about us as an employer?

See reviews on  Indeed  –   Glassdoor  –  Kununu (German)

Stay tuned and connect with us!

@straumannjobs at LinkedIn – Xing – Twitter – Instagram – Pinterest – Quora

Please understand that we do not need external support by recruiting agencies and consultants to fill this vacancy. Thank you for respecting this.

To apply for this job please visit jobs.smartrecruiters.com.