Associate Regulatory Affairs
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:
Associate Regulatory Affairs (f/m/x) part or full-time
- You are the person responsible for regulatory compliance in our company (MDR, Article 15)
- You are the point of contact for internal & external inquiries regarding regulatory matters
- You design and maintain economical and easily applicable (RA) processes
- Organization and execution of internal trainings in the area of Regulatory Affairs
- Active, independent & systematic communication with authorities & regulatory representatives (info on product changes, answering queries...)
- Participation in product certification audits & authority audits (notified body, FDA, etc.)
- Work closely with Product Development to create & maintain regulatory strategy for all products & services in alignment with corporate strategy
- Support and administration of the post market surveillance system
Your skills and qualifications
- Basic knowledge & understanding of regulatory relevant national & international regulations (laws, regulations, directives, standards) including Medical Device Regulations (MDR)
- Overview of and understanding of the interrelationships of national and international regulatory requirements regarding medical devices
- Ability to evaluate the conformity of documentation with these regulations
- Fundamental technical understanding and hands-on mentality
- Initial experience in project management
- Structured & pragmatic way of working
- Very good knowledge of German or English (written & spoken)
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.
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
Flexible working hours
Broad range of tasks
Delicious coffee & healthy snacks
Ergonomic work stations
Your letter of application
Done? This is what happens next
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.
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.
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.
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.