regulatory-affairs-specialist

m/w/x

BHS Technologies GmbH (www.bhs-technologies.com) is a determined and rapidly growing high-tech company with a focus on medical technology. We develop, produce and market highly innovative technologies to make surgeons and doctors better, healthier and safer at work. We use state-of-the-art technology to exceed our customers' fundamental expectations in every respect, but especially in ergonomics and ease of use.

To strengthen our team at the Innsbruck location, we are filling the following exciting position with immediate effect:

 

Regulatory Affairs Specialist (f/m/x) full-time (38.5h)

 

Your tasks

  • Coverage of the MDR Article 15 requirement ("Person responsible for regulatory compliance")
  • Contact point for all internal & external enquiries regarding Regulatory Affairs (RA)
  • Design and maintenance of economical and easily applicable (RA) processes
  • Organisation and implementation of trainings in the field of RA
  • Active, independent & systematic communication with the authorities & representatives of the authorities (info on product changes, answering queries...)
  • Active & independent representation of the company externally with regard to RA in coordination with the management
  • Participation in product certification audits & authority audits (notified body, FDA, etc.)
  • In collaboration with product development:
    • Creation & maintenance of the regulatory strategy for all products & services in coordination with the corporate strategy (incl. budget, costs, opportunities & risks)
    • Maintenance & updating of the technical files
    • Responsibility for the international market approval of our products (creation, testing, adaptation & maintenance of approval documents for our medical products incl. process responsibility)
    • Organisation and management of clinical trials and studies
    • Monitoring of product descriptions, creation & management of type labels/UDI
    • Creation & maintenance of an overview of country-specific regulatory requirements & their compliance levels, incl. a (risk) assessment of upcoming changes (report- ing)
  • Post Market Surveillance:
    • Support and administration of the Post Market Surveillance System, preparation of the associated annual report, as well as monitoring of feedback regarding non-conformities.
    • Research & evaluation of changes to the respective regulatory provisions & any normative requirements incl. communication of the relevant content to the team

Your skills and qualifications

  • Knowledge & understanding of national & international regulations (laws, ordinances, directives, standards) relevant for approval, including medical device law (MDR)
  • Overview and understanding of the interrelationships of national and international regulatory provisions regarding medical devices
  • Ability to assess the conformity of documents with these regulations
  • Technical understanding and hands-on mentality
  • Project management experience
  • Precise, structured & pragmatic way of working
  • Very good written & spoken English

Your future working environment

We work almost exclusively "paperless" and, in addition to the obligatory, classic office tools from Microsoft, we use a modern IT environment with the tools CONFLUENCE as a documentation and development system and JIRA for project organisation, with which we organise our workload in small teams via two-week sprints. We pay attention to ergonomics in our workplaces as well as in our working environment, and personal working hours are freely configurable. Our communication is open, questioning the status quo is our daily business and we try to use open-book management to enable independent decision-making and evaluation by all employees. The characters and interests in our team are diverse and colourful, and we all work together to ensure that there is enough freedom for each character. Our joint activities were and are varied, very challenging, sometimes sprawling, instructive and very ambitiously goal-oriented, but always remained very friendly, respectful and above all one thing: very interesting!

photo: BHS Technologies

Have we made you curious?

Then apply directly via the contact form, your contact person is Eva Stöckl - we are looking forward to your application!

Please note that the minimum basic salary for this position (collective agreement for employees in the metal industry, employment group IV after two years in the employment group) is EUR 2,969.62 gross (14x). There is an explicit readiness for overpayment.

Benefits

We asked our colleagues, and this is what our team said about the top benefits of working at BHS Technologies:

Extraordinary team spirit and great colleagues

Team events

Flexible working hours

Broad range of tasks

Delicious coffee & healthy snacks

Ergonomic work stations

Your letter of application

  • Done? This is what happens next

  • 1

    Confirmation notice

    Thank you for your application! We appreciate the time you have invested in applying to BHS. Right after sending your application, you will receive a notification saying the upload and sending has been successful.

  • 2

    Written or phone feedback/response

    Shortly after sending your application you will hear from us – either per phone or per email. We let you know the estimated duration of the process and might ask you few detailed questions about your application.

  • 3

    Invitation to the interview

    You have impressed us! We would now like to invite you to an interview to get to know you better and to answer all the possible questions you may have for us. Very important - come as you are! Only that way we can find out if we are right for each other.

  • 4

    Your first day at BHS - The warmest welcome to the BHS team!

    Your team leader will help you with the first steps. They show you everything that is important and make sure that you feel comfortable in our team. After two weeks of intensive getting to know each other and being introduced to the company, you will have a much better picture of us. We are very grateful to you and are happy that you have chosen and decided for us and would like to welcome you!

Why not try a new way?

The world of microsurgery needs something novel, something ground-breaking. And that is why BHS Technologies was founded in the first place. Sometimes, a change of perspective is enough to see things in a new way.