At a Glance
- Tasks: Lead regulatory affairs for the UK, ensuring compliance and market access for innovative medical devices.
- Company: Join a global leader in healthcare with a focus on innovation and collaboration.
- Benefits: Competitive salary, career development opportunities, and a supportive work environment.
- Other info: Dynamic role with opportunities for growth in a multinational organisation.
- Why this job: Make a real impact on healthcare by shaping regulatory strategies for cutting-edge products.
- Qualifications: 8-10 years in Regulatory Affairs, strong knowledge of UK regulations, and leadership skills.
The predicted salary is between 60000 - 80000 £ per year.
The Associate Director, RA UK & Ireland provides senior regulatory leadership for the United Kingdom market, ensuring compliance with UK and applicable EU regulatory requirements while enabling timely market access and lifecycle management of DePuy Synthes products. This role has a significant impact on business continuity and growth by shaping local regulatory strategy, managing regulatory risk, and partnering closely with Commercial, Quality, Supply Chain, and Global Regulatory teams.
Responsibilities
- Lead and oversee regulatory affairs activities for the UK local market in alignment with global and regional regulatory strategies.
- Ensure compliance with UK regulatory requirements, applicable EU MDR provisions, internal policies, and quality system standards.
- Provide strategic regulatory guidance to support product registrations, variations, renewals, and lifecycle management activities.
- Serve as the senior regulatory affairs point of contact and escalation lead for the UK local operating company.
- Partner with Commercial, Quality, Supply Chain, and Global Regulatory teams to support compliant product distribution and business initiatives.
- Monitor regulatory changes and assess potential impacts to products, portfolios, and business operations in the UK.
- Lead the UKCA marking strategy for DePuy Synthes.
- Support internal audits, external audits, and health authority inspections related to regulatory activities.
- Lead, coach, and develop regulatory team members, fostering strong regulatory capability and compliance culture.
- Engage proactively and shape regional policy initiatives critical to business strategy, continuity, and growth.
Required Qualifications
- Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, or related discipline.
- Typically 8-10 years of progressive experience in Regulatory Affairs within medical devices, healthcare, or another regulated industry.
- Strong working knowledge of UK regulatory requirements and regulatory operating models.
- Demonstrated experience leading regulatory strategy and execution at the country level.
- Experience supporting audits, inspections, and health authority interactions.
- Ability to manage regulatory risk and complex stakeholder environments effectively.
- Experience with UKCA regulations.
- Language: English required.
- Travel: Limited; occasional domestic or regional travel.
Preferred Qualifications
- Advanced degree in a scientific or regulatory field.
- Experience working in a multinational or matrixed organization.
- Familiarity with international regulatory operating models.
- Experience supporting orthopedic or medical device product portfolios.
- Exposure to regulatory strategy development and regulatory transformation initiatives.
- Regulatory Affairs Certification (RAC) or equivalent.
- Strong communication, leadership, and decision-making skills.
Location: Leeds, United Kingdom or Cork, Ireland.
Associate Director, RA UK & Ireland in Leeds employer: J&J Family of Companies
DePuy Synthes is an exceptional employer that prioritises employee growth and development within a collaborative and innovative work culture. Located in the vibrant cities of Leeds and Cork, we offer competitive benefits, including opportunities for professional advancement and a commitment to regulatory excellence that empowers our team members to make a significant impact in the healthcare sector.
Contact Details:
J&J Family of Companies Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director, RA UK & Ireland in Leeds
✨Tip Number 1
Network like a pro! Reach out to folks in the industry on LinkedIn or at events. A friendly chat can open doors that applications alone can't.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Knowing their regulatory challenges can help you stand out as a candidate who’s ready to hit the ground running.
✨Tip Number 3
Showcase your leadership skills! Be ready to discuss how you've led teams or projects in the past, especially in regulatory affairs. We want to see how you can drive compliance and strategy.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you're genuinely interested in joining our team.
We think you need these skills to ace Associate Director, RA UK & Ireland in Leeds
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Associate Director role. Highlight your experience in regulatory affairs, especially in the UK market, and showcase any leadership roles you've had. We want to see how your background aligns 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 team at StudySmarter. Be sure to mention specific experiences that relate to the job description.
Showcase Your Regulatory Knowledge:We’re looking for someone with a strong grasp of UK regulatory requirements. In your application, don’t shy away from discussing your knowledge of UKCA regulations and any relevant experiences you’ve had with audits or inspections.
Apply Through Our Website:To make sure your application gets the attention it deserves, apply directly through our website. It’s the best way for us to keep track of your application and ensure it reaches the right people!
How to prepare for a job interview at J&J Family of Companies
✨Know Your Regulatory Stuff
Make sure you brush up on UK regulatory requirements and EU MDR provisions. Being able to discuss these confidently will show that you’re not just familiar with the basics, but that you can lead regulatory strategy effectively.
✨Showcase Your Leadership Skills
As an Associate Director, you'll need to demonstrate your ability to lead and develop a team. Prepare examples of how you've coached team members or managed complex stakeholder environments in the past. This will highlight your leadership capabilities.
✨Understand the Business Impact
Be ready to discuss how regulatory affairs influence business continuity and growth. Think about specific instances where your regulatory decisions have positively impacted product registrations or market access, and be prepared to share those stories.
✨Engage with Cross-Functional Teams
Since this role involves partnering with Commercial, Quality, and Supply Chain teams, think of examples where you've successfully collaborated across departments. Highlighting your teamwork skills will show that you can navigate the complexities of a multinational organisation.
