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 and inclusivity.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Dynamic work environment with a focus on career development and diversity.
- Why this job: Make a real impact on health by shaping regulatory strategies for groundbreaking products.
- Qualifications: 8-10 years in Regulatory Affairs with strong UK regulatory knowledge.
The predicted salary is between 60000 - 80000 £ per year.
This job is with Johnson & Johnson, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. 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.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
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.
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:
- Required: 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. Certifications: Regulatory certifications preferred but not required.
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, RA UK & Ireland employer: Johnson & Johnson
At Johnson & Johnson, we pride ourselves on being an inclusive employer that values diversity and fosters a supportive work culture. Located in Leeds, our team enjoys a collaborative environment where innovation thrives, alongside ample opportunities for professional growth and development. With a commitment to employee well-being and a focus on meaningful healthcare solutions, we empower our staff to make a profound impact on health for humanity.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director, RA UK & Ireland
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how they align with yours. This will help you answer questions more authentically and show that you're genuinely interested in being part of their team.
✨Tip Number 3
Practice your interview skills with a friend or mentor. Mock interviews can help you get comfortable with common questions and refine your answers. Plus, it’s a great way to receive constructive feedback!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Associate Director, RA UK & Ireland
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 what we're looking for!
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 DePuy Synthes. Be sure to mention any specific experiences that relate to the job description.
Showcase Your Skills:Don’t forget to highlight your skills in managing regulatory risk and your knowledge of UKCA regulations. We’re looking for someone who can navigate complex stakeholder environments, so make sure to provide examples of how you've done this in the past.
Apply Through Our Website:We encourage you to apply through our website for the best chance of being noticed. It’s the easiest way for us to keep track of your application and ensure it gets to the right people. Plus, it shows you’re serious about joining our team!
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 latest 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 Their Values
Johnson & Johnson values inclusivity and diversity. Familiarise yourself with their Credo and be prepared to discuss how you can contribute to fostering an inclusive culture within the regulatory team.
