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For Companies At a Glance
- Tasks: Lead regulatory activities and collaborate on innovative product development projects.
- Company: Join a diverse and inclusive team at Olympus, a leader in healthcare innovation.
- Benefits: Enjoy competitive salary, generous leave, private medical cover, and wellness support.
- Other info: Dynamic environment with opportunities for growth and collaboration across teams.
- Why this job: Make a real impact in healthcare by ensuring compliance and driving innovation.
- Qualifications: Experience in Regulatory Affairs within medical devices and strong communication skills.
The predicted salary is between 50000 - 65000 £ per year.
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 the 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.
Qualifications
- 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.
Competencies
- 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 and generous annual leave entitlement.
- Private medical cover.
- Comprehensive company pension scheme.
- Annual health check with BUPA, funded by the company.
- Employee Assistance Program to support health, mental and emotional wellbeing.
- Subsidised staff restaurant and free parking at HQ.
- Discounts on gym and wellness memberships, cashback and discounts with major UK retailers.
Additional Information
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. If you would like to bring your talents to this role at Olympus, please apply.
Regulatory Affairs Program Manager employer: Olympus Corporation
Contact Detail:
Olympus Corporation Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Program Manager
✨Tip Number 1
Network like a pro! Reach out to folks in the regulatory affairs space, especially those who work with medical devices. A friendly chat can open doors and give you insights that job descriptions just can't.
✨Tip Number 2
Prepare for interviews by brushing up on global regulatory frameworks. We want you to show off your knowledge and how it aligns with our mission. Think about real-life examples where you've tackled regulatory challenges.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, drop a quick thank-you note. It shows your enthusiasm and keeps you fresh in their minds. Plus, it’s a great way to reiterate your fit for the role.
✨Tip Number 4
Check out our website for openings and apply directly! We love seeing candidates who are genuinely interested in joining us. Tailor your approach to highlight how your experience aligns with our values and the role.
We think you need these skills to ace Regulatory Affairs Program Manager
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to 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!
Showcase Your Collaboration Skills: Since this role involves working with various teams, emphasise your ability to collaborate and communicate effectively. Share examples of how you've worked cross-functionally in past roles to get us excited about your teamwork!
Highlight Your Regulatory Knowledge: Demonstrate your understanding of global regulatory frameworks and your experience with audits and compliance. We’re keen to see how you’ve navigated complex regulatory landscapes in your previous positions.
Apply Through Our Website: Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensure you’re considered for the role. We can’t wait to hear from you!
How to prepare for a job interview at Olympus Corporation
✨Know Your Regulatory Stuff
Make sure you brush up on global regulatory frameworks, especially those relevant to the medical device industry. Be ready to discuss how your experience aligns with the responsibilities of the role, like managing CAPAs and supporting product development.
✨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 regulatory affairs. Highlight any successful projects where you facilitated teamwork across departments.
✨Be Audit-Ready
Since you'll be contributing to audits, it’s crucial to demonstrate your understanding of audit processes. Share experiences where you’ve supported audits or resolved findings, and explain how you ensure compliance in your work.
✨Stay Updated on Regulations
Regulatory requirements are always evolving, so show that you’re proactive about staying informed. Discuss how you monitor changes in regulations and assess their impact on business operations, which will reflect your commitment to the role.