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- Tasks: Support Regulatory Compliance by creating and updating Technical Files and conducting audits.
- Company: Join a leading Medical Device company known for innovative solutions and growth.
- Benefits: Enjoy a dynamic work environment with opportunities for professional development.
- Why this job: Be part of a team that impacts healthcare through regulatory excellence and innovation.
- Qualifications: Must have experience in Regulatory Affairs within the Medical Device sector and knowledge of MDD/MDR.
- Other info: This role is based in West Yorkshire and offers a chance to grow your career.
The predicted salary is between 36000 - 60000 £ per year.
Job Description Cure Talent are delighted to be working with a well-established Medical Device company that supply and distribute innovative Medical Devices. Due to their continued growth and success, we have an exciting opportunity for a Senior Regulatory Affairs Associate to join them in West Yorkshire. As the new Senior Regulatory Affairs Associate, you will be working closely with the Regulatory Affairs Manager to support Regulatory Compliance across the business, creating, reviewing and updating Technical Files, PMS and Auditing. To be successful in this role, you will be an experienced Regulatory Affairs professional with a proven background in the Medical Device sector. Technical knowledge and experience should encompass Technical File management, PMS activities and MDD/MDR compliance. Key Role Responsibilities MDD & MDR Compliance Technical File creation, review and updating Post Market Surveillance Regulatory Compliance in line with ISO 13485 Internal Auditing Required Skills, Experience & Education Proven experience in the Medical Device Sector within a RA role Experience of Technical File management and/or creation Post Marketing Surveillance experience Proven experience with MDD, MDR and ISO 13485 If this sounds like y…
Senior Regulatory Affairs Associate employer: Cure Talent
Contact Detail:
Cure Talent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Associate
✨Tip Number 1
Make sure to network with professionals in the Medical Device sector. Attend industry conferences or webinars where you can meet people who work in Regulatory Affairs. This can help you gain insights and potentially get referrals.
✨Tip Number 2
Stay updated on the latest changes in MDD, MDR, and ISO 13485 regulations. Subscribe to relevant newsletters or join online forums where these topics are discussed. This knowledge will not only help you in interviews but also show your commitment to the field.
✨Tip Number 3
Consider reaching out to current or former employees of the company you're applying to. They can provide valuable insights into the company culture and the specific expectations for the Senior Regulatory Affairs Associate role.
✨Tip Number 4
Prepare to discuss specific examples from your past experience that demonstrate your skills in Technical File management and Post Market Surveillance. Being able to articulate your hands-on experience will set you apart from other candidates.
We think you need these skills to ace Senior Regulatory Affairs Associate
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Senior Regulatory Affairs Associate position. Understand the key responsibilities and required skills, especially focusing on MDD, MDR compliance, and Technical File management.
Tailor Your CV: Customize your CV to highlight your relevant experience in the Medical Device sector. Emphasize your background in Regulatory Affairs, particularly any roles involving Technical File management, Post Market Surveillance, and compliance with ISO 13485.
Craft a Strong Cover Letter: Write a compelling cover letter that connects your experience to the specific requirements of the role. Mention your familiarity with MDD and MDR regulations, and how your previous roles have prepared you for this position.
Proofread Your Application: Before submitting your application, carefully proofread all documents. Ensure there are no spelling or grammatical errors, and that your information is clear and concise. A polished application reflects your attention to detail, which is crucial in Regulatory Affairs.
How to prepare for a job interview at Cure Talent
✨Show Your Regulatory Knowledge
Make sure to highlight your experience with MDD, MDR, and ISO 13485 during the interview. Be prepared to discuss specific examples of how you've managed Technical Files and ensured compliance in previous roles.
✨Demonstrate Your Attention to Detail
As a Senior Regulatory Affairs Associate, attention to detail is crucial. Share instances where your meticulousness led to successful audits or compliance checks, showcasing your ability to maintain high standards.
✨Prepare for Technical Questions
Expect technical questions related to Post Market Surveillance and Technical File management. Brush up on relevant regulations and be ready to explain your approach to these processes clearly and confidently.
✨Emphasize Team Collaboration
Since you'll be working closely with the Regulatory Affairs Manager, emphasize your teamwork skills. Discuss how you've collaborated with cross-functional teams to achieve regulatory compliance and support business goals.
