Regulatory Affairs Manager – PerkinElmer, Inc. Turku2.9.2021
About the job
PerkinElmer is currently looking for
Regulatory Affairs Manager
Turku, Finland / Regulatory & Clinical Affairs
The Turku Site, with 650 employees, represents one of PerkinElmer’s major manufacturing and product development sites for newborn, maternal fetal health, and prenatal screening. As the global market leader in newborn screening, our solutions have tested over 560 million babies worldwide for life-threatening diseases.
- Provide high quality regulatory advice as a valued strategic partner to the business
- Prepare/submit global in vitro diagnostic device registration documents for international agencies worldwide
- Provide support and coaching for RA Specialists
- Oversee the implementation of international regulatory requirements of specified new and existing products as well as follow the specified geographic region medical device /IVD regulations.
- Interact with global regulatory affairs managers/distributors in order to expedite approval of upcoming and pending registrations to ensure timely approval for market release
- Participation on project teams to provide strategic and tactical guidance to meet regulatory requirements
- Ensure that regulatory considerations are evaluated and addressed during change control process, and implement regulatory action plans based on the changes
- Review and approve promotional materials and product labeling
- BSc or MSc or equivalent in biochemistry/biotechnology
- Strong Regulatory Affairs experience in the medical device or pharmaceutical industry or with medical product regulatory agencies
- Understanding of CE IVD (98/79/EY) Directive, EU IVDR and international MD/IVD regulations such as NMPA, FDA and Health Canada
- Some expertise in regulatory topic areas such as artificial intelligence, electrical devices, software, cybersecurity, clinical evaluation is advantage
- Independent, self-directed person with excellent organization and communication skills
- Excellent English (spoken and written)
- Some level of Finnish language skills, as parts of our organization operate in Finnish and some documentation is available only in Finnish
What We Offer
- Opportunity to work in a global team
- Dynamic and innovative culture
- Focus on career development
- Collaborative and diverse environment
PerkinElmer Turku Site is a drug free site and a medical examination for new employees includes a drug test.
For more information please contact Leader of Global Regulatory Affairs Yifeng Li on +358503791124 (Aug 30th, at 11.00 and Sep 06th, at 11.00).
If you are interested in the position and feel that you have the necessary skills and experience, please send your application and CV by September 15th via the link below.