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- Tasks: Lead regulatory activities for innovative medical devices and ensure compliance across global markets.
- Company: Join a patient-focused company that values integrity, innovation, and impact.
- Benefits: Enjoy competitive salary, generous leave, private medical cover, and wellness support.
- Other info: We embrace diversity and foster an inclusive environment where everyone can thrive.
- Why this job: Make a real difference in healthcare while collaborating with diverse teams.
- Qualifications: Experience in Regulatory Affairs within the medical device industry is essential.
The predicted salary is between 50000 - 60000 £ per year.
As a Regulatory Affairs Program Manager, you will coordinate regulatory activities across a diverse product portfolio, ensuring alignment and regulatory compliance across markets. You will serve as a strategic partner to internal teams, helping to define regulatory pathways and ensure consistent, compliant practices across the organisation. Combining strategic oversight with execution, this role offers significant visibility across regulatory, quality, manufacturing, and product development functions.
Your responsibilities:
- Lead coordination of regulatory activities across the product portfolio to ensure alignment with global regulatory strategies.
- Collaborate with regulatory counterparts to ensure consistency and standardisation across regions.
- Facilitate development of regulatory plans for new product development projects, novel technologies, and emerging market segments.
- Support responses to regulatory authority requests and inquiries.
- Contribute to both internal and external regulatory audits, ensuring preparedness and compliance.
- Monitor and interpret evolving global regulatory requirements and assess business impact.
- Support resolution of internal and external audit findings, including oversight of regulatory CAPAs.
- Develop and maintain regulatory procedures to support consistent and compliant operations.
- Provide regulatory support to cross‑functional initiatives, including manufacturing engineering, quality assurance, product development, and clinical affairs.
Essential:
- Experience in Regulatory Affairs within the medical device or healthcare industry.
- Strong understanding of global regulatory frameworks.
- Demonstrated experience supporting product development or regulatory strategy.
- Experience supporting audits and regulatory authority interactions.
- Ability to manage multiple programs and stakeholders simultaneously.
- Strong communication and cross‑functional collaboration skills.
Highly Desirable:
- Experience within complex medical device portfolios.
- Familiarity with global regulatory submissions and lifecycle management.
- Experience managing CAPAs and regulatory compliance programs.
Company values:
- Patient Focus – We put patients at the heart of everything.
- Integrity – We do the right thing.
- Innovation – We look for new ways to make things better.
- Impact – We take accountability and get things done.
- Empathy – We care for one another and work together.
Benefits:
- Competitive salary.
- Generous annual leave entitlement.
- Private medical cover eligibility.
- Comprehensive company pension scheme.
- Annual health check with BUPA, funded by us.
- Employee Assistance Program to support health, mental and emotional well‑being.
- Subsidised staff restaurant and free parking at HQ.
- Discounted gym and wellness memberships, cashback and discounts with major UK retailers.
We value the diversity of individuals, perspectives, and lifestyles, and prioritise inclusion and mutual respect. We are committed to fostering a non‑discriminatory, inclusive work environment where everyone feels a sense of belonging. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to this role at Olympus, to apply.
Regulatory Affairs Program Manager employer: OLYMPUS EUROPA SE & CO. KG
Contact Detail:
OLYMPUS EUROPA SE & CO. KG Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Program Manager
✨Network Like a Pro
Get out there and connect with people in the regulatory affairs field! Attend industry events, join relevant online forums, and don’t be shy about reaching out on LinkedIn. We all know that sometimes it’s not just what you know, but who you know!
✨Ace the Interview
Prepare for your interviews by researching the company and its products thoroughly. Think about how your experience aligns with their needs, especially in regulatory compliance. We recommend practising common interview questions and having a few thoughtful questions ready to show your interest.
✨Showcase Your Skills
When you get the chance to meet potential employers, make sure to highlight your experience in managing regulatory activities and your understanding of global frameworks. We want to see how you can bring value to their team, so don’t hold back!
✨Apply Through Our Website
Don’t forget to apply directly through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who take the initiative to engage with us directly.
We think you need these skills to ace Regulatory Affairs Program Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Program Manager role. Highlight your experience in regulatory affairs, especially within the medical device or healthcare industry. We want to see how your skills align with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how you can contribute to our mission at KeyMed. Be sure to mention specific experiences that demonstrate your understanding of global regulatory frameworks.
Showcase Your Communication Skills: Strong communication is key in this role. In your application, highlight examples where you've successfully collaborated with cross-functional teams or managed multiple stakeholders. We love seeing how you can bring people together to achieve compliance!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team at KeyMed!
How to prepare for a job interview at OLYMPUS EUROPA SE & CO. KG
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of global regulatory frameworks, especially those relevant to medical devices. Be ready to discuss how you've navigated these in past roles and how you can apply that experience to the position.
✨Showcase Your Collaboration Skills
This role requires strong communication and cross-functional collaboration. Prepare examples of how you've worked with different teams in the past, particularly in product development or regulatory strategy, to demonstrate your ability to be a strategic partner.
✨Prepare for Scenario Questions
Expect questions about how you'd handle specific regulatory challenges or audits. Think through potential scenarios and how you would approach them, highlighting your problem-solving skills and ability to manage multiple stakeholders.
✨Align with Company Values
Familiarise yourself with the company's values like patient focus and integrity. Be prepared to share how your personal values align with theirs and provide examples of how you've embodied these principles in your work.