At a Glance
- Tasks: Lead regulatory affairs for innovative medical devices in the UK and Ireland.
- Company: Join Johnson & Johnson, a leader in healthcare innovation.
- Benefits: Competitive salary, career growth, and a chance to impact health globally.
- Other info: Opportunity to work in a multinational team with a focus on personal development.
- Why this job: Shape regulatory strategy and ensure compliance in a dynamic healthcare environment.
- Qualifications: 8-10 years in Regulatory Affairs with strong UK regulatory knowledge.
The predicted salary is between 70000 - 90000 £ per year.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Role Context: DePuy Synthes
DePuy Synthes is recruiting for an Associate Director, RA UK & Ireland, located in Leeds, United Kingdom or Cork, Ireland. Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes.
Job Overview
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 within a highly regulated environment.
Key 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 for 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.
- Ensuring proactive engagement and shaping of regional policy initiatives that are critical to business strategy, continuity, and growth.
Qualifications
Education
- Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline (required).
- Advanced degree in a scientific or regulatory field (preferred).
Experience and Skills
- 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.
Preferred
- 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.
Other
- Language: English required.
- Travel: Limited; occasional domestic or regional travel.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law.
Associate Director, Regulatory Affairs UK & Ireland in Leeds employer: Johnson & Johnson
At Johnson & Johnson, we are committed to fostering a dynamic and inclusive work environment that prioritises employee growth and well-being. As an Associate Director in Regulatory Affairs, you will be part of a pioneering team in Leeds or Cork, where you will have the opportunity to lead regulatory strategies that directly impact healthcare innovation. Our culture encourages collaboration and continuous learning, ensuring that you can thrive while making a meaningful difference in the lives of patients across the UK and Ireland.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director, Regulatory Affairs UK & Ireland in Leeds
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those at Johnson & Johnson or DePuy Synthes. A friendly chat can open doors and give you insights that might just help you stand out.
✨Tip Number 2
Prepare for interviews by knowing your stuff! Brush up on UK regulatory requirements and be ready to discuss how your experience aligns with the role. We want to see your passion for regulatory affairs shine through!
✨Tip Number 3
Showcase your leadership skills! As an Associate Director, you'll need to lead teams and manage complex situations. Share examples from your past where you've successfully navigated challenges and driven results.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you're serious about joining our team at Johnson & Johnson.
We think you need these skills to ace Associate Director, Regulatory Affairs 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 within medical devices, and showcase how your skills align with the job description. We want to see how you can bring value to our team!
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 your background makes you a perfect fit for DePuy Synthes. Don’t forget to mention any specific achievements that demonstrate your expertise.
Showcase Your Leadership Skills:As an Associate Director, you'll be leading a team, so make sure to highlight your leadership experience in your application. Share examples of how you've successfully managed teams or projects in the past, and how you foster a culture of compliance and growth.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us that you’re genuinely interested in joining our team at DePuy Synthes!
How to prepare for a job interview at Johnson & Johnson
✨Know Your Regulatory Stuff
Make sure you brush up on UK regulatory requirements and the 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 successfully managed teams in the past, especially in high-pressure environments like audits or health authority inspections.
✨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 access or lifecycle management.
✨Engage with the Interviewers
Don't just answer questions; engage with your interviewers. Ask them about their current challenges in regulatory affairs and how you could help. This shows your proactive approach and genuine interest in the role at DePuy Synthes.
