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- Tasks: Lead regulatory compliance for innovative IVD products and ensure quality standards are met.
- Company: Established IVD manufacturer with a focus on growth and innovation.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional development.
- Why this job: Make a real impact in the medical device industry while advancing your career.
- Qualifications: Master's degree in life sciences and 3-5 years of regulatory experience required.
- Other info: Join a dynamic team and contribute to cutting-edge healthcare solutions.
The predicted salary is between 36000 - 60000 £ per year.
An exciting opportunity to join an established and growing IVD manufacturer and support a growing Regulatory Affairs Department. In this role you will be responsible to deliver end to end regulatory package under ODM-Distributor scheme in compliance with established quality management system, overseeing (but not limited to) initial compilation of design control evidence, supplier management, incoming inspection and product release process, product submission, post‑market surveillance, vigilance and associated reporting. The role is responsible for maintaining product and site regulatory & quality compliance to maintain license/registration once granted.
Responsibilities
- Preparing and compiling regulatory documentation, coordinating and executing regulatory submission in compliance with ISO13485, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), Medical Device Approvals (510(k)), and other country requirements as appropriate.
- Advising staff and project team members on data and information required for successful license applications and coordinating their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission.
- Ensure Quality Assurance release of incoming goods, intermediate and final product obligations.
- Ensure Vigilance reporting obligations.
- Be a point of contact for regulatory & quality compliance issues.
- Interface with Competent Authorities for reporting incidents, and field safety actions, including FSCA, FSN, recalls, MDRs (medical device reporting).
- Evaluate Product/Processes Non‑Conformances, determine whether their need to be reported to the Competent Authorities.
- Support QMS organization during regulatory inspections or certifications audits.
- Perform any other duties as reasonably requested from the Company from time to time.
- Conduct all duties in compliance with company Quality Management System and cGMP, GCP and ISO13485 requirements.
Requirements
- Master degree or equivalent in life sciences and 3/5 years of experience in a regulatory/quality role.
- Level required in the function (e.g.: validation, finance, quality control).
- Experience in medical device / IVD / biotech industry.
- Experienced in meeting with, making presentations to, and negotiating with regulators.
- Specific technical competencies required for the role (e.g.: GMP, GLP exposure, FDA exposure, IT packages, technical writing skills).
- Significant specialist knowledge of regulation as applied to medical devices, in vitro diagnostic medical devices, or Biologics (93/42/EC, 98/79/EC directives, 510(k), PMA, CMDR, etc.).
- Specialist knowledge of vigilance processes for US, EU and other jurisdictions as appropriate (MDR, MEDDEV 2.12, etc.)
Please note that you MUST have the full right to work in the UK and be able to be office based 3x a week.
Senior Regulatory Compliance Officer - IVDs employer: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Compliance Officer - IVDs
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory compliance field, especially those who work with IVDs. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO13485 and FDA regulations. We want you to be able to discuss how your experience aligns with the role's requirements confidently.
✨Tip Number 3
Showcase your expertise! Bring examples of your past work in regulatory submissions and compliance during interviews. This will help us see how you can hit the ground running in our team.
✨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 take that extra step to connect with us directly.
We think you need these skills to ace Senior Regulatory Compliance Officer - IVDs
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Regulatory Compliance Officer role. Highlight your experience in regulatory affairs, especially with IVDs and compliance with ISO13485. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory compliance in the IVD sector. Share specific examples of your past achievements that relate to the responsibilities listed in the job description.
Showcase Relevant Experience: When filling out your application, be sure to showcase your relevant experience in medical devices and IVDs. Mention any specific regulations you've worked with, like FDA 21 CFRs or MDR, as this will catch our eye!
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of applications better and ensures you don’t miss out on any important updates from us!
How to prepare for a job interview at Cpl Life Sciences
✨Know Your Regulations
Make sure you brush up on the key regulations relevant to the role, such as ISO13485 and IVD 2017/746. Being able to discuss these confidently will show that you’re not just familiar with the requirements but also understand their practical implications.
✨Prepare Your Documentation Examples
Have specific examples of regulatory documentation you've prepared in the past ready to discuss. This could include submissions or compliance reports. Highlighting your experience with the ODM-Distributor scheme will be particularly impressive.
✨Showcase Your Communication Skills
Since the role involves advising staff and interfacing with Competent Authorities, practice articulating complex regulatory concepts clearly. You might even want to prepare a mini-presentation on a relevant topic to demonstrate your ability to communicate effectively.
✨Understand the Company’s Quality Management System
Familiarise yourself with the company’s Quality Management System and how it aligns with cGMP, GCP, and ISO13485. Being able to discuss how you can contribute to maintaining compliance will set you apart from other candidates.
