Regulatory affairs Manager to INVISIO - Hvidovre - Denmark
INVISIO is a fast-growing high-tech company placed in Hvidovre, Denmark nearby the Airport. INVISIO develops and markets advanced headsets- and communications systems to the ARMY, Military Special Forces, Police and Rescue units worldwide.
We are seeking a self-driven and solutions oriented Regulatory affairs Manager to strengthen, and further develop, the Regulatory Affairs (RA) area in INVISIO. As RA Specialist, you will be responsible for both individual activities within the Quality Management Department (RA/QA), as well as manage cross-functional RA improvement activities, to further raise the efficiency (level of compliance and speed) of the regulatory processes.
Through both operational- and project related tasks and initiatives, the RA Specialist will work in close cooperation with especially R&D and Sales & Marketing but also with Manufacturing and Supply Chain.
The RA Specialist’s main area of responsibility will be to:
- Further develop INVISIO’s QMS’ processes related to Regulatory Affairs
- Contribute with RA expertise in Product Development Projects
- Contribute with RA expertise in Tenders/Bidding Programs
- Conduct regular System Safety/Product Risk Management assessments w. R&D
- Lead general Improvement Projects related to the Regulatory Affairs area
- Further consolidate compliance documentation related to various regulatory requirements as:
- EU - Directives (RoHS, REACH, LVD, EMC, etc.) and related standards
- US - legislation (i.e. Export Regulations) and standards
- Other national/regional regulatory requirements and standards (MIL-STD, DEFSTAN, etc).
The right candidate for this position will have a strong drive, and with both a systematic- and pragmatic approach to problem-solving and improvements - in a constantly changing environment. The right candidate is focused on ensuring compliance, but also acknowledge that to achieve long term goals, often require compromises, in the short term.
Technical skills and competences:
To match INVISIO’s expectations to the candidate, the right person will probably have an Engineering degree, but first of all, have comprehensive experience from a similar position within the Regulatory Affairs area. A background from i.e. the Military-, Medical Device-, or maybe the Pharmaceutical industry, would be an advantage.
Furthermore, the right candidate is/has:
- Highly skilled within regulations for electronic devices (EU (CE-marking), US, etc.)
- Experience with Reliability- and Environmental Testing and Standards.
- A high ability to interpret complex regulations and deduct the vital requirements relevant to INVISIO
- Experience with, or knowledge of, Quality Management System Requirements
- Excellent skills in English (company language) - orally as in writing
- Preferably min. 5 years of experience from a similar Regulatory Affairs position.
You are an open-minded person with a strong drive and passion, not only for your expertise area, but for how your knowledge within RA, can support the business.
- An analytical and systematic approach in relation to complex problem solving
- Excellent interpersonal-, verbal- and written communication skills.
- Strong planning- and organizational skills.
- The ability to positively influence and build relationships with key stakeholders
You are enthusiastic with a high degree of personal initiative, integrity and stamina, and you like to work with others in a dynamic and international environment.
INVISIO offers an independent and demanding job in a fast-growing high-tech Company in an enthusiastic and international atmosphere. In this job you will gain influence on your work-day and on how things are done in general. Every day is different and due to the rapid growth of the company, nothing remains status-quo. As INVISIO continues to grow and expand its activities, you will constantly be challenged and be able to develop professionally as well as personally. INVISIO has a culture where high transparency, competency, teamwork and employee satisfaction is in focus and where everybody has a high degree of freedom to form their own job and influence decision making.
For further information about the position, please contact Director, Quality Management Michael Søndersted, Tel: +45 5372 7729 or send your application and CV to HR Manager Anja Pelby via the "Ansøg" link, Marked “Regulatory Affairs Specialist” before March 18th, 2018.
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