At a Glance
- Tasks: Lead regulatory strategy for healthcare products and ensure compliance with EU regulations.
- Company: Join GE HealthCare, a leader in innovative healthcare solutions.
- Benefits: Competitive salary, flexible benefits, and a supportive work culture.
- Other info: Dynamic environment with opportunities for growth and collaboration.
- Why this job: Make a real impact in healthcare by shaping regulatory strategies.
- Qualifications: 10+ years in Regulatory Affairs with strong leadership skills.
The predicted salary is between 80000 - 100000 £ per year.
This role provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. Interprets simple internal and external business challenges and recommends best practices to improve products, processes or services. Stays informed of industry trends that may influence work.
Responsibilities:
- Leadership & Strategy
- Lead and develop the European Regulatory Affairs team, fostering a high-performance and collaborative culture.
- Define and execute regulatory strategies aligned with GE HealthCare’s global objectives.
- Represent Regulatory Affairs in cross-functional leadership forums and strategic initiatives.
- Regulatory Compliance
- Ensure compliance with EU MDR and other applicable European regulations.
- Knowledge of PRRC under MDR, and UKRP under UK MDR, ensuring product conformity and regulatory documentation integrity.
- Oversee regulatory submissions, CE / UKCA marking processes, Importer and Distributor responsibilities, and interactions with Notified Bodies and Competent Authorities.
- Operational Excellence
- Drive continuous improvement in regulatory processes and systems.
- Monitor regulatory changes and assess impact on GE HealthCare’s product portfolio.
- Support audits, inspections, and regulatory due diligence activities.
- Stakeholder Engagement
- Collaborate with Quality, Legal, Commercial, and Product teams to ensure regulatory alignment.
- Provide expert guidance and training on European regulatory requirements.
- Represent GE HealthCare in industry associations and regulatory forums as needed.
Required Qualifications:
- Bachelor’s or Master’s degree in Life Sciences, Engineering, or related field.
- Minimum 10 years of experience in Regulatory Affairs, with significant exposure to European medical device regulations.
- Proven leadership experience, including team management and strategic planning.
- Strong knowledge of EU MDR, UK MDR, and relevant guidance documents.
- EU and UK IVD regulatory expertise desirable.
- Excellent communication, negotiation, and stakeholder management skills.
Preferred Characteristics:
- Experience working in a global or matrixed organization.
- Familiarity with digital health technologies and software as a medical device (SaMD).
- Ability to influence and lead through change.
- Strong growth mindset and proactive approach.
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.
Director, Regulatory Affairs, Europe employer: GE Healthcare
At GE HealthCare, we pride ourselves on being an exceptional employer, offering a dynamic work environment in the heart of Europe where innovation meets collaboration. Our commitment to employee growth is evident through our leadership development programmes and a culture that values diversity and inclusion, ensuring every voice is heard. With competitive benefits and a focus on operational excellence, we empower our team to drive meaningful change in the healthcare industry.
StudySmarter Expert Advice🤫
We think this is how you could land Director, Regulatory Affairs, Europe
✨Join Compliance Communities
Get involved in compliance and risk communities — both online and offline. Look for forums, LinkedIn groups, or even local meetups where compliance pros hang out. You never know who might drop a job opportunity your way!
✨Attend Industry Conferences
Keep an eye out for compliance and risk management conferences and workshops in your area. These events are a goldmine for networking, and they often have job boards or recruiters on-site looking for new talent. Plus, it’s a chance to learn what's trending in the field.
✨Leverage Your University Career Services
If you’ve recently graduated or are still studying, head over to your university's career services. Many companies, including those in compliance, actively recruit fresh talent through these services, so make sure you tap into that resource.
✨Showcase Your Knowledge Online
Start writing articles or blog posts about compliance topics that interest you. Share them on platforms like LinkedIn to demonstrate your knowledge and passion. This not only builds your presence in the field but can also catch the attention of companies like GE Healthcare looking for candidates who are engaged and informed.
We think you need these skills to ace Director, Regulatory Affairs, Europe
Some tips for your application 🫡
Show Your Understanding of Compliance:In the compliance-risk field, it's super important to showcase your understanding of regulations and risk management frameworks. Highlight any relevant coursework, certifications (like ICA or AML), or even projects that demonstrate your knowledge and commitment to this area. We want to see how you can navigate this complex landscape!
Quantify Your Achievements:When detailing your experience, try to quantify your achievements. For example, if you've previously worked on a project that improved compliance metrics or reduced risk exposure, give us the numbers! This data-driven approach really stands out to hiring managers in compliance-risk roles.
Tailor Your CV to Reflect Relevant Skills:Make sure your CV highlights skills that are particularly relevant to compliance, like attention to detail, analytical thinking, and report writing. Ensure these are easy to spot – consider using bullet points to break down your responsibilities and achievements for maximum impact!
Craft a Motivating Cover Letter:In your cover letter, let us know why you’re excited about the compliance-risk role at GE Healthcare. Share what motivates you about compliance, and how you believe you can contribute to our mission. This is your chance to showcase not only your skills but also your passion for this important field!
How to prepare for a job interview at GE Healthcare
✨Master the Regulations
Brush up on key compliance regulations relevant to the industry you're applying to. Familiarising yourself with specific laws and frameworks used in your field will give you an edge during technical questions. Show that you’re not just aware of them but can also apply them—think real-life scenarios!
✨Show Your Analytical Skills
Compliance roles really focus on analytical skills, so be prepared for case studies or situational questions during the interview. We've got to demonstrate how we approach risk assessments or compliance audits, possibly drawing on examples from past experiences or university projects. Bring some thoughtful case scenarios to discuss!
✨Know Your Tools
Get comfortable with commonly used compliance software and tools. Familiarity with platforms like RSA or MetricStream can really impress during your interview, as it shows you're ready to hit the ground running. If you’ve had any experience with them, make sure to highlight that!
✨Align with Company Culture
Since it's a full-time position, show your long-term commitment and interest in the company’s mission and values. Dive into how your ethics and professional philosophy align with GE Healthcare’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!
