Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead regulatory compliance and ensure quality standards in a dynamic manufacturing environment.
- Company: Join Hawk3 Talent Solutions, a forward-thinking organization dedicated to high-quality product delivery.
- Benefits: Enjoy 25 days of holiday, pension plans, and healthcare perks after probation.
- Why this job: Be part of a team that values compliance and customer service while making a real impact.
- Qualifications: Experience in regulatory affairs, especially with medical devices, is essential.
- Other info: Hybrid work options available for a better work-life balance.
The predicted salary is between 36000 - 60000 £ per year.
Regulatory Affairs Manager
Location: Gloucester
Employment Type: Permanent, Full-time (Monday – Friday, Hybrid Options Available)
Salary: Competitive, DOE
Overview
Hawk3 Talent Solutions is seeking a Regulatory Affairs Manager to join a manufacturing organization located in Gloucester.
The successful candidate will be responsible for ensuring business compliance with relevant legislation and quality standards to support the company s overarching objectives of delivering cost-effective, high-quality products while providing exemplary customer service. Key responsibilities include:
– Maintaining current knowledge of both domestic and international regulatory requirements and effectively communicating this information to management and project teams.
– Supporting the processes necessary to ensure that the Quality Management System is upheld in alignment with applicable regulatory and statutory requirements, including ISO 13485, 21 CFR 820, MDD 93/42/EEC, Regulation (EU) 2017/745, and ISO 14971.
– Issuing advisory notices as necessary, in accordance with the MDD, MDR, and FDA regulatory requirements (21 CFR 803).
– Developing, preparing, and maintaining high-quality technical files, design dossiers, and any other required documentation for regulatory submissions and approvals.
Qualifications:
– Proven experience in regulatory affairs, particularly in a managerial capacity.
– Essential experience with medical devices.
– Completion of Lead Auditor training.
– Strongly desirable experience with MDR
Benefits :
25 days holidays plus bank holidays
Pension – Nest
Single Vitality Healthcare upon successful completion of the probationary period
Perkbox
Hawk 3 Talent Solutions are operating as an employment agency on behalf of its client.
To Apply please follow the application process for the site this job is advertised on or email your CV to (url removed). By applying for the above position and providing your personal data to us you understand that your data will be processed in line with our Privacy Policy. To view our full Privacy Policy please visit our website.
Hawk 3 Talent Solutions are committed to the selection, recruitment and development of the best people, basing judgements solely on suitability for the job. Whilst we endeavour to respond to all applications individually, due to high volumes, this is not always possible. Thank you for your interest in this role and we look forward to working with you in the future
Regulatory Affairs Manager employer: Hawk 3 Talent Solutions
Contact Detail:
Hawk 3 Talent Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager
✨Tip Number 1
Make sure to stay updated on the latest regulatory changes in the medical device industry. This knowledge will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with ISO 13485 and MDR. Engaging in discussions can provide insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of how you've ensured compliance in previous roles. Highlighting your hands-on experience with regulatory submissions will set you apart from other candidates.
✨Tip Number 4
Familiarize yourself with the company’s products and their regulatory challenges. Showing that you understand their business and how you can contribute will make a strong impression during the interview.
We think you need these skills to ace Regulatory Affairs Manager
Some tips for your application 🫡
Understand the Role: Make sure you fully understand the responsibilities of a Regulatory Affairs Manager. Familiarize yourself with relevant legislation and quality standards such as ISO 13485 and MDR, as this knowledge will be crucial in your application.
Tailor Your CV: Customize your CV to highlight your experience in regulatory affairs, especially in relation to medical devices. Emphasize any managerial roles you've held and relevant certifications like Lead Auditor training.
Craft a Strong Cover Letter: Write a compelling cover letter that outlines your passion for regulatory affairs and how your background aligns with the company's objectives. Mention specific experiences that demonstrate your ability to maintain compliance and manage quality systems.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors or inconsistencies. A polished application reflects your attention to detail, which is essential in regulatory affairs.
How to prepare for a job interview at Hawk 3 Talent Solutions
✨Know Your Regulations
Make sure you have a solid understanding of both domestic and international regulatory requirements, especially those related to medical devices. Be prepared to discuss how these regulations impact the company's operations and product quality.
✨Showcase Your Experience
Highlight your proven experience in regulatory affairs, particularly in a managerial capacity. Be ready to provide specific examples of how you've successfully navigated regulatory challenges in previous roles.
✨Prepare for Technical Questions
Expect questions about the Quality Management System and relevant standards like ISO 13485 and MDR. Familiarize yourself with these standards and be prepared to discuss how you would ensure compliance within the organization.
✨Demonstrate Communication Skills
Since effective communication is key in this role, be prepared to explain how you would convey complex regulatory information to management and project teams. Use examples from your past experiences to illustrate your communication style.
