Regulatory Affairs Specialist

Do you want to grow your career in regulatory affairs at a leading tech company while making a difference in a fast-paced, team-oriented environment?

We are seeking a Regulatory Affairs Specialist with a strong, systematic approach to join our Global Quality Management department in Copenhagen.

We offer you the chance to make a real impact as our company rapidly expands its product portfolio and grows in complexity. If you thrive in a dynamic, cross-functional environment and want to broaden your expertise while working with supportive and experienced colleagues, this is an opportunity for you.

About the job

At INVISIO, our Regulatory Affairs function is more than a compliance checkpoint, it’s a trusted business partner, enabling innovation and growth across the organization. As a Regulatory Affairs Specialist, you’ll play a key facilitator role, guiding and mentoring colleagues while ensuring we meet the highest standards of compliance.

You’ll collaborate with the Regulatory Affairs Manager to ensure the RA team has the resources needed to handle a growing product portfolio, including tasks related to new projects as well as maintaining existing products.

The role also includes collaborating with various departments of the company, including Product Management, R&D, Sales (tenders), and Product Marketing, obtaining a broad understanding of how the company operates cross-functionally and interacts with a diverse range of colleagues.

Your primary responsibilities are as follows (but not necessarily limited to):

• Support with various doc-management activities within the regulatory area.
• Create environmental test specifications according to the product description.
• Gather various regulatory documentation (e.g. RoHS and REACH)
• Manage RoHS verification tests with external lab.  
• Plan and coordinate environmental testing with external labs.
• With R&D, prepare test samples and test method in the certification phase.
• Support tender/bidding program with evidence of environmental qualification.
• Support with RA expertise in Tenders/Bidding Programs
• Coordinate testing of products by external labs where required or preferred.
• Support on further development of the processes within Regulatory Affairs.
• Further consolidate compliance docs. related to various RA-requirements as:
• EU – Directives (RoHS, LVD, EMC, PPE etc.) and rel. standards (CE-Marking)
• US – Applicable requirements and standards
• Other national/reg. regulatory requirements and standards
• Customer specified requirements like MIL-STD, DEFSTAN, etc.

The right candidate will have a large influence on the contents of the job and future personal development.

About you

We’re looking for someone who thrives on collaboration, brings a service-minded approach, and pays close attention to detail. Your pragmatic mindset and ability to find solutions, balancing regulatory requirements with the art of the possible, will help drive our business forward.

You must have a demonstrated commitment to regulatory compliance and quality standards, and the capacity to quickly grasp complex, cross-functional environments. The ability to adapt rapidly to new challenges and manage multiple tasks and stakeholders efficiently is essential. The ideal candidate is proactive, focused on continuous improvement, and skilled at streamlining processes for greater efficiency.

You must have several years of experience in regulatory affairs, ideally within the medical device or electronics industries, which closely align with INVISIO’s regulatory context. An engineering background in the electronics field is highly desirable.

The following qualifications are required:

• Minimum 5 years of experience from RA-position in similar industries (medical devices, electronic industry)
• Understanding of regulatory frameworks (E.g.: CE, EMC, Safety, RoHS, REACH).

• Familiarity with technologies used in R&D and/or Manufacturing.
• Ability to read and interpret complex regulatory- and technical documentation.
• Excellent written and verbal communication skills.
• Ability to cooperate with people with very different skillsets and experience.
• Familiarity with QMS principles and practices.
• Knowledge of internal or external auditing processes.

Additional information

This position is based at our headquarters in Hvidovre, Copenhagen, and cannot be handled remotely or as a hybrid function. Please note that relocation assistance is not available for this role.

The position will involve some travel throughout the year. Fluency in English is essential as it is the primary language used for all company communications.

As part of our recruitment process, we are conducting a background check on the selected candidate.

For further information regarding this position, please contact our Recruiting Coordinator, Sofie Ingemann Aamodt, at sat@invisio.com. 

What we offer 

• A chance to join a fast-growing, high-tech company in a highly enthusiastic and international atmosphere.
• A workplace that supports both professional and personal growth, providing opportunities for career advancement and learning from experienced colleagues.
• A flexible work schedule, primarily from HQ in Copenhagen, with the ability to sometimes work from home. 
• A culture of teamwork, passion, innovation, and a customer-focused mindset as our guiding principles.

How to apply

Follow the link to submit your application before November 9. A cover letter is not required for this position. However, we kindly ask that you include a brief introduction about yourself in your CV. Please also explain why you believe you are the right fit for this role. This information will help us better understand your background and motivation during the selection process.

All candidates will receive a response via email, so make sure to check your spam folder. We expect to conduct interviews on an ongoing basis.

We believe in equal opportunities for all and encourage all suitable candidates to apply for our open positions.

We look forward to hearing from you!