Reference: JLSQR
Location: South Wales
Salary: £50k+
Type: Full-time
Start Date: ASAP
Just Life Sciences is in search of a skilled Regulatory Affairs Associate to join our Global Client’s team in South Wales. This hybrid role will require you to work in the office for two days a week.
About the Role
As a Regulatory Affairs Associate, you will play a crucial role in assisting the Director of Regulatory Affairs with various technical aspects, including the compilation, submission, and maintenance of registrations and technical documentation. This is to ensure compliance with country-specific requirements for relevant Regulatory Authorities.
Qualifications
Responsibilities:
- Maintain and update relevant Global, local Regulatory, and compliance databases.
- Prepare and maintain technical documentation, including labeling and information for IVDR, FDA, CE, and UKCA.
- Compile and submit regulatory submissions to global regulatory authorities, including FDA, CE, and UKCA, both as a legal manufacturer and on behalf of PLM customers.
- Provide ongoing regulatory guidance to project teams throughout product and process development.
- Ensure that all company products comply with the regulations of the regions where they are sold.
- Stay informed about national and international legislation, guidelines, and industry best practices.
- Conduct literature research on legal requirements for territory registrations and regulatory affairs updates.
- Perform Post Market Surveillance activities, including data collection, collation, and evaluation.
- Support performance evaluation studies for new and existing products.
- Communicate effectively with customers throughout the project lifecycle.
- Prepare product submissions to meet strict deadlines.
- Utilize specialist computer software and resources such as EUDAMED.
- Develop clear and accessible product labels and instructions for use.
- Advise scientists and manufacturing teams on regulatory requirements.
- Review company practices and provide guidance on system changes and process improvements.
- Actively participate in global external audits related to ISO, MDSAP, FDA, IVDR, notified bodies, and regulatory inspections.
- Maintain regulatory procedures and processes.
If you are interested in this exciting opportunity, please email your CV to Justyn Withey at justyn@justlifesciences.com or apply now.
Contact Information
Just Life Sciences 2a Foster Drive, Cardiff, CF23 9BZ
Mobile: 07968 551450
Email: justyn.withey@justlifesciences.com
Join us in shaping the future of Regulatory Affairs in South Wales! Apply now to be a part of our dynamic team.
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