Senior Regulatory Affairs

Senior Regulatory Affairs

Full-Time 60000 - 80000 € / year (est.) No home office possible
Kinetica

At a Glance

  • Tasks: Lead compliance strategy and oversee quality departments to ensure regulatory excellence.
  • Company: Dynamic company in West Yorkshire focused on innovation and growth.
  • Benefits: Competitive salary, leadership opportunities, and a chance to influence business strategy.
  • Other info: Collaborative environment with opportunities for professional development and mentorship.
  • Why this job: Join a high-performing team and make a real impact in the regulatory landscape.
  • Qualifications: Proven senior leadership experience in compliance and strong knowledge of ISO 13485.

The predicted salary is between 60000 - 80000 € per year.

We are seeking an experienced senior Quality leader to define and deliver the strategic direction of the compliance function at the company in West Yorkshire. As well as ensuring full regulatory compliance, you will oversee the quality and regulatory departments and support commercial growth and operational excellence. As a key member of the Senior Leadership Team, you will influence business strategy and lead a high-performing team.

  • Set and deliver the compliance strategy aligned to business objectives
  • Act as Responsible Person under MDR/UKCA, ensuring ongoing ISO 13485 compliance
  • Lead and maintain Quality Management Systems and accreditations
  • Ensure audit readiness across the business and supply chain, managing audits and compliance programmes
  • Oversee CAPA, change management, complaints analysis, and continuous improvement
  • Collaborate with Sales, Marketing, Procurement, and key customers on regulatory and commercial matters
  • Lead, develop, and mentor UK-based compliance teams, embedding a “right first time” culture

Proven senior leadership experience in compliance roles within regulated industries. Strong knowledge of ISO 13485 and medical device or consumer health environments. Experience building and managing robust QMS and compliance frameworks. Commercially aware with the ability to balance risk and business needs.

Senior Regulatory Affairs employer: Kinetica

At our company in West Yorkshire, we pride ourselves on being an exceptional employer that fosters a culture of collaboration and innovation. With a strong commitment to employee development, we offer numerous growth opportunities and a supportive environment where your contributions directly impact our strategic direction. Join us to be part of a high-performing team dedicated to excellence in regulatory affairs and quality management, all while enjoying the benefits of working in a vibrant and dynamic location.

Kinetica

Contact Detail:

Kinetica Recruiting Team

StudySmarter Expert Advice🤫

We think this is how you could land Senior Regulatory Affairs

Tip Number 1

Network like a pro! Reach out to industry professionals on LinkedIn or attend local meetups. We can’t stress enough how important it is to make connections that could lead to job opportunities.

Tip Number 2

Prepare for interviews by researching the company and its compliance strategies. We recommend practising common interview questions and having your own questions ready to show your interest in their regulatory affairs.

Tip Number 3

Showcase your leadership skills! When discussing your experience, highlight how you’ve led teams and influenced business strategy. We want to see how you can bring that 'right first time' culture to the table.

Tip Number 4

Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.

We think you need these skills to ace Senior Regulatory Affairs

Regulatory Compliance
ISO 13485
Quality Management Systems (QMS)
Audit Management
CAPA (Corrective and Preventive Action)
Change Management
Complaints Analysis

Some tips for your application 🫡

Tailor Your CV:Make sure your CV reflects the specific skills and experiences that align with the Senior Regulatory Affairs role. Highlight your leadership experience in compliance and any relevant ISO 13485 knowledge to catch our eye!

Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for the role and how your past experiences can help us achieve our compliance strategy. Be genuine and let your personality come through.

Showcase Your Achievements:When detailing your previous roles, focus on your achievements rather than just responsibilities. Use metrics where possible to demonstrate how you’ve led teams or improved compliance processes in the past.

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!

How to prepare for a job interview at Kinetica

Know Your Regulations

Make sure you brush up on ISO 13485 and the MDR/UKCA regulations. Being able to discuss these in detail will show that you’re not just familiar with them, but that you can apply this knowledge strategically within the company.

Showcase Leadership Experience

Prepare examples of how you've led teams in compliance roles before. Highlight specific instances where your leadership influenced business strategy or improved operational excellence. This will demonstrate your capability to be a key member of their Senior Leadership Team.

Emphasise Collaboration Skills

Since the role involves working closely with Sales, Marketing, and Procurement, think of examples where you successfully collaborated across departments. This will illustrate your ability to influence and drive compliance while supporting commercial growth.

Prepare for Scenario Questions

Expect questions about managing audits, CAPA, and change management. Prepare scenarios where you’ve navigated challenges in these areas, showcasing your problem-solving skills and commitment to a 'right first time' culture.