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For Companies At a Glance
- Tasks: Ensure compliance with regulations and manage documentation for product registration.
- Company: Join a growing Biotechnology company in Newcastle, focused on innovation and quality.
- Benefits: Enjoy a permanent role with opportunities for growth and development.
- Why this job: Be part of a dynamic team making a real impact in the medical device industry.
- Qualifications: Bachelor’s degree in Life Science and experience in regulatory affairs required.
- Other info: Work primarily on-site in Newcastle with a supportive, team-oriented culture.
The predicted salary is between 36000 - 60000 £ per year.
CY Partners Recruitment is delighted to be partnering with a growing Biotechnology company based in Newcastle with their search for a Regulatory Affairs Officer. Reporting to the QARA Manager in this key role, you will ensure compliance with quality standards, regulatory requirements, and best practices within the organisation. This is an exceptional role for someone who is looking to take a step into a dynamic environment, with projected significant growth for the organisation and the post-holder.
Main Duties and Responsibilities
- Regulatory Submissions - compile and submit regulatory documentation to relevant agencies for product registration and license renewals.
- Compliance Monitoring - stay updated on current regulations and guidelines ensuring company practices adhere to them and identifying potential compliance risks.
- Vigilance Reporting – report vigilance events to competent authorities.
- Communication with Agencies - communicate with regulatory agencies, responding to queries and addressing concerns.
- Internal Consultation - provide regulatory advice to cross-functional teams (R&D, manufacturing, marketing) on product development, labelling, and market access strategies.
- Documentation Management - maintain accurate and organised regulatory documentation, including records of submissions, correspondence with agencies, and product information.
- Risk Assessment - identify and assess potential regulatory risks associated with new products or changes to existing products.
- Post-Market Surveillance - monitor product performance post-approval, reporting any safety concerns to regulatory agencies.
Qualifications, Skills, and Experience
- Bachelor’s degree or equivalent experience in a Life Science subject.
- Strong understanding of ISO 13485:2016, MHRA, and IVDR regulatory frameworks.
- Experience in regulatory affairs within the medical device industry.
- Excellent attention to detail regarding existing and new documentation.
- Experience or knowledge of IVD medical devices and Quality Systems.
- Positive, team-focused approach to working and problem-solving.
- Competent with Microsoft Word, Excel, PowerPoint, and SharePoint.
Location – The role is permanent and to be primarily based at the site in Newcastle upon Tyne.
CY Partners Scientific Recruitment - Regulatory Affairs Officer (permanent, Newcastle, IVDr) employer: Bionow
Contact Detail:
Bionow Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land CY Partners Scientific Recruitment - Regulatory Affairs Officer (permanent, Newcastle, IVDr)
✨Tip Number 1
Familiarise yourself with the latest regulations and guidelines related to IVDr and ISO 13485:2016. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in the regulatory affairs sector, especially those working with medical devices. Attend industry events or webinars to make connections that could lead to valuable insights or referrals.
✨Tip Number 3
Prepare to discuss specific examples of how you've ensured compliance in previous roles. Highlight any experience you have with regulatory submissions or risk assessments, as these are key responsibilities for the role.
✨Tip Number 4
Showcase your teamwork skills by preparing to discuss how you've collaborated with cross-functional teams in the past. Emphasising your ability to provide regulatory advice to different departments will set you apart from other candidates.
We think you need these skills to ace CY Partners Scientific Recruitment - Regulatory Affairs Officer (permanent, Newcastle, IVDr)
Some tips for your application 🫡
Understand the Role: Read the job description thoroughly to understand the key responsibilities and qualifications required for the Regulatory Affairs Officer position. Tailor your application to highlight how your skills and experiences align with these requirements.
Highlight Relevant Experience: In your CV and cover letter, emphasise any previous experience in regulatory affairs, particularly within the medical device industry. Mention specific projects or tasks that demonstrate your understanding of ISO 13485:2016, MHRA, and IVDR frameworks.
Craft a Strong Cover Letter: Write a compelling cover letter that not only introduces yourself but also explains why you are passionate about this role and how you can contribute to the company's growth. Use specific examples to illustrate your problem-solving skills and team-focused approach.
Proofread Your Application: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. Ensure that your formatting is consistent and professional, as attention to detail is crucial in regulatory affairs.
How to prepare for a job interview at Bionow
✨Know Your Regulations
Familiarise yourself with ISO 13485:2016, MHRA, and IVDR regulatory frameworks. Being able to discuss these in detail will show your understanding of the industry and demonstrate your preparedness for the role.
✨Showcase Your Experience
Prepare specific examples from your past experience in regulatory affairs, especially within the medical device industry. Highlight any successful submissions or compliance monitoring you have conducted to illustrate your capabilities.
✨Demonstrate Attention to Detail
Since this role requires excellent attention to detail, be ready to discuss how you ensure accuracy in documentation and compliance. You might even want to bring a sample of your work to showcase your meticulousness.
✨Engage with Cross-Functional Teams
Be prepared to talk about your experience working with different teams, such as R&D and marketing. Emphasising your collaborative approach will show that you can effectively provide regulatory advice across various departments.
