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- Tasks: Manage regulatory compliance and quality assurance for IVD products.
- Company: Join a growing IVD manufacturer with a strong reputation in the industry.
- Benefits: Enjoy an attractive salary, benefits package, and opportunities for professional growth.
- Why this job: Be part of a dynamic team making a real impact in healthcare through regulatory excellence.
- Qualifications: Master’s degree in life sciences and experience in regulatory/quality roles required.
- Other info: Opportunity to interface with authorities and support regulatory inspections.
The predicted salary is between 43200 - 72000 £ per year.
Job Title: Quality & Regulatory Specialist – IVDs Job Type: 12 month fixed term contract
Attractive salary and package
An exciting opportunity to join an established and growing IVD manufacturer and support a growing Regulatory Affairs Department. The Regulatory Affairs & Quality Department primary role is to establish the Quality/Regulatory link between products and the end user. Reporting to the Chief Regulatory Affairs and Quality Officer, the Quality and Regulatory Affairs Specialist is 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 evidences, 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.
The role is also responsible for supporting other regulatory and quality affairs team members as needed, including training and guidance as appropriate.
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.
Ensuring Quality Assurance release of incoming goods, intermediate and final product obligation.
Ensure Supplier management 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).
Support QMS organization during regulatory inspections or certifications audits.
Conduct all duties in compliance with company Quality Management System and cGMP, GCP and ISO13485 requirements.
Master’s degree or equivalent in life sciences and significant experience in a regulatory/quality role.
Experience in medical device / IVD / biotech industry.
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).
Regulatory and Quality Compliance Manager employer: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory and Quality Compliance Manager
✨Tip Number 1
Familiarize yourself with the specific regulations and standards mentioned in the job description, such as ISO13485 and IVD 2017/746. This knowledge will not only help you understand the role better but also demonstrate your commitment to compliance during interviews.
✨Tip Number 2
Network with professionals in the regulatory affairs and quality compliance field, especially those who have experience in IVDs or medical devices. Engaging with industry groups or attending relevant conferences can provide valuable insights and connections that may lead to job opportunities.
✨Tip Number 3
Prepare to discuss your previous experiences related to regulatory submissions and quality management systems. Be ready to share specific examples of how you've successfully navigated compliance challenges in past roles, as this will showcase your expertise and problem-solving skills.
✨Tip Number 4
Stay updated on the latest trends and changes in regulatory requirements for medical devices and IVDs. Being knowledgeable about current events in the industry can give you an edge in discussions and show that you are proactive about your professional development.
We think you need these skills to ace Regulatory and Quality Compliance Manager
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Quality & Regulatory Specialist position. Understand the key responsibilities and required qualifications, especially the importance of compliance with ISO13485 and FDA regulations.
Tailor Your CV: Customize your CV to highlight relevant experience in regulatory affairs and quality management, particularly in the IVD or medical device sectors. Emphasize any specific projects or roles that align with the responsibilities outlined in the job description.
Craft a Strong Cover Letter: Write a compelling cover letter that connects your background to the requirements of the role. Discuss your experience with regulatory submissions, quality assurance processes, and any direct interactions with competent authorities.
Highlight Relevant Skills: In your application, make sure to showcase your knowledge of regulations such as 93/42/EC and 98/79/EC, as well as your ability to manage supplier obligations and conduct post-market surveillance. This will demonstrate your fit for the position.
How to prepare for a job interview at Cpl Life Sciences
✨Understand the Regulatory Landscape
Make sure you have a solid grasp of the regulations relevant to IVDs, such as ISO13485 and FDA 21 CFRs. Be prepared to discuss how these regulations impact product development and compliance.
✨Showcase Your Experience
Highlight your previous experience in regulatory affairs and quality management, especially in the medical device or biotech industry. Use specific examples to demonstrate your expertise in managing regulatory submissions and compliance.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world situations. Think about past challenges you've faced in regulatory compliance and how you overcame them, particularly in relation to product submissions and audits.
✨Emphasize Team Collaboration
This role involves working closely with various teams. Be ready to discuss how you have successfully collaborated with cross-functional teams in the past, particularly in training and guiding team members on regulatory requirements.
