Regulatory Affairs Expert
Wipak is part of the family owned Wihuri Group, a diverse Finnish conglomerate that can trace its origins back over 100 years. Wipak operates in Europe and Asia and our vision is to be the most sustainable flexible packaging company – with a promise to reduce the company’s CO2 footprint to ZERO by 2025.
In Wipak we are curious and open minded, we trust and challenge each other and we work together today for a more sustainable planet tomorrow.
To strengthen our organization towards our growth based strategy we are currently looking for a
REGULATORY AFFAIRS EXPERT
To develop and ensure that the state of the art regulation requirements are met in the medical device and health care facilities market on global level. In this position you will work closely in cooperation with Quality, Operations, Sales and Group Operations and report to Global Sales Director.
Your key responsibilities are
- Ensuring Product Safety.
- Ensuring compliance with regulatory requirements such as MDR, ISO 13485:2016, ISO 11607, ISO 868-5, as well as other valid regulations for the production of medical packaging.
- Adherence to all safety regulations.
- Proactively supporting the development of a safety culture.
- Acting as the person responsible for regulatory compliance as required in MDR (article 15).
- Acting as the contact person towards the customers in regulatory affairs.
- Providing globally necessary information, support and documents of our products for the national registrations.
- Ensuring that documentation related to the regulations are up to date.
What we expect from you
- Minimum five years of experience within regulatory compliance in the medical business.
- Direct experience and understanding of medical, clinical, quality and /or regulatory processes in medical devices and hospital care facilities.
- Possessing expertise of FDA and its’ requirements.
- Good knowledge of quality management systems and methods.
- Master’s degree in Engineering or Economics with focus on Quality Management or relevant professional experience.
- Solid communication skills in Finnish and in English. Other languages are advantage.
As a person, you are analytical, self-driven and deliver to promise. With excellent communication skills you understand your role as a change agent operating in diverse organization. You have intercultural competencies and are highly customer oriented. Location of this position is Nastola, Finland.
We offer you
A permanent position and an independent, challenging and rewarding work at the heart of packaging solution business in a professional environment with lots of opportunities. For further information please contact Mr. Michel Terwolbeck, Global Sales Director Health at email@example.com.
If you feel that you are well suited for the above opportunity, please apply by leaving your CV and references together with your availability and salary expectations by 20th of November, 2019 the latest. Find more about us at www.wipak.com.