Regulatory Affairs Program Manager – GE Healthcare Finland Oy
27.3.2022Työpaikkakuvaus
GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
Job Description Summary
GE Healthcare, a leading global health technology provider has strong presence in Finland. We are 700+ people from over 25 countries, helping healthcare providers improve patient care. We’re looking for Regulatory Affairs Program Manager who provides subject matter expertise for new product introductions and maintenance programs. You will work within a team of Regulatory Affairs professionals and with cross-functional program teams to ensure that global regulatory requirements are fulfilled.
Key responsibilities/essential functions include:
- Provides regulatory strategy and direction to the business regarding medical device industry regulatory requirements for product launch, premarket submissions/registrations and post market compliance, working closely with regulatory bodies globally
- Manages regulatory submissions projects by working across the regulatory organization and cross functionally with other functions such as Engineering
- Participates as team member on all assigned new product introductions and maintenance programs
- Assesses changes in existing products and determines the need for new / revised licenses or registrations
- Ensures compliance with pre- and post-market product requirements as well as clinical investigations
- Reviews and approves advertising and promotion material ensuring it is consistent with approved claims for regulated products
- Educates, trains & advises others to ensure compliance with regulatory requirements
- Supports regulatory inspections
Qualifications
- Bachelor’s Degree in a Scientific, Engineering or Healthcare discipline
- Regulatory Affairs / Quality Assurance experience in the medical device industry or with medical product regulatory agencies
- Experience with management of regulatory projects in global regulatory organizations and regulatory agency interactions
- Project management skills; ability to prioritize, plan, evaluate & execute deliverables for established tactical goals
- Excellent verbal and written communication and presentation skills with the ability to speak and write clearly and convincingly in English
We offer
- Work with talented experts in the health technology industry and in the field of medical device Quality and Regulatory Affairs – in a team with great spirit
- Work in a diverse multicultural environment and in a global company
- Office near Pasila railway station in central Helsinki with own on-site parking, gym, great café and restaurant supported by the employer
- Competitive compensation and benefits
Inclusion and Diversity
GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.