Environmental System and Regulatory Affairs Officer

Location: Stockholm
Role: Environmental Systems and Regulatory Affairs Officer

The company offers solutions and support to increase the independence of disabled or elderly people, and to enable them to live an active life - on their terms - and to facilitate for their care providers and family.

We are a global company with sales in more than 20 countries and are a market leader in this field. The head office is in Stockholm, Sweden and manufacturing is located at six sites distributed across North America, Asia and Europe. In 2017, revenue totalled MEUR 285.

We are a team of some 1150 employees and are passionate about what we do. Our commitment is tied to our awareness that our efforts make a difference in the lives of individuals. We are also driven by the ongoing need to continuously improve, enhance and develop our solutions. We are "Making everyday life easier"!

Our global Quality Team is spread between North America and Europe, and for our Quality department in Sweden, specialised in transfer products, we are recruiting to further expand our Quality Team.

Reporting to the Head of Operations Patient Handling, the role will give you the opportunity to grow in a truly international company. You will be responsible for ensuring product compliance and maintain and improve the existing portfolio.

Key Responsibilities:
* Participate in internal and external audits.
* stay updated on the development of relevant standards and regulations.
* Coordinate and be responsible for the CAPA process.
* Ensure that requirements for market access of medical devices, including CE marking and government registration with regulatory authorities, are fulfilled in accordance with relevant regulations.
* Be the company's contact person for regulatory authorities for medical devices.
* Implement and coordinate regulatory reporting for accidents, incidents and recalls.
* Support other company functions in matters concerning Regulatory Affairs.
* Be responsible for the environmental management system and ensure that requirements from the ISO 14001 standard are met.
* Structure, plan and implement processes, writing routines and creating forms for relevant areas to cover, EMS and RA.

Your background:
- You have a MSc or at least 5 years experience from working in a similar role within MedTech or similarly controlled environment.
- Experience from regulatory reporting in EU and US (FDA). You are good at Project Management and can independently drive change projects.
- A good knowledge of the Medical Device Directive, MDD, is required, and if you also have knowledge of the Medical Device Regulation, MDR, that is a merit.
- Your English is fluent. Swedish, and any other European or Asian language is an asset.

If you or someone you know fits this description then let me, Joakim Hauge, know as soon as possible:
J.hauge@nonstop-recruitment.com