Galena Pharma Oy is a Finnish pharmaceutical company located in Kuopio. Our core service is developing and contract manufacturing medicines and medical devices. Our comprehensive service concept includes product development, registration, market surveillance and vigilance, and product life cycle management. Learn more about our company at www.galena.fi.
To support our international growth, we seek an experienced and competent Regulatory Expert— for a permanent position— to manage medical device registration in the regulatory affairs department.
As a Regulatory Expert, you will get to develop your expertise and utilize your skills in various areas. The job offers extensive, responsible, and versatile expert work in an international and inspiring team.
Your responsibilities include:
- managing international regulatory affairs projects in non-EU countries
- managing regulatory affairs projects for new EU countries
- preparing documentation related to new medical device MDR registrations
- preparing country-specific documentation and compiling applications
- maintaining the Eudamed -database
- monitoring and implementing legislation
- maintaining and updating standard operating procedures
- reviewing the content of marketing materials
We expect you to perform your responsibilities independently. You will cooperate closely with the product development, safety, and quality departments.
To succeed in this role, you need
- experience working independently with medical devices
- knowledge of medical device legislation (e.g., MDD, MDR, and the most critical ISO standards)
- pharmacist’s degree or another applicable university degree
- fluency in oral and written English
- skills in maintaining and developing an electronic database
- ability to manage multiple projects simultaneously
- self-initiation, planning, accuracy, diligence, and interpersonal skills
- good customer service skills
Send your application and resume with salary expectations by March 5, 2023, to firstname.lastname@example.org.
For more information about the position, contact the Head of RA, Heidi Taipale.
Head of Regulatory Affairs and R&D, PRRC
heidi.taipale (at) galena.fi
Mob: +358 40 4509899