Job Title: Regulatory Affairs Specialist
We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team.
About the Role
This is an exciting opportunity for a skilled professional to play a key role in ensuring the company's products meet regulatory requirements worldwide. As a Regulatory Affairs Specialist, you will be responsible for regulatory submissions, annual reporting, and maintaining compliance with international standards and regulations.
You will work closely with interdisciplinary teams to ensure the effectiveness of our Quality Management System (QMS) and coordinate internal and external audits. Additionally, you will support the team in obtaining and retaining country-specific regulatory registrations on a global basis.
Main Responsibilities:
* Support day-to-day regulatory activities and handle multiple projects related to regulatory compliance enhancements.
* Assist in the implementation of MDSAP within the organisation.
* Support the team to obtain/retain country-specific regulatory registrations on a global basis.
* Work with the Commercial Team/Distributors to ensure country-specific registration activities are understood and appropriately addressed.
* Work closely with QA for internal and external audits, including notified body audits as required.
* Support the wider team to ensure product manufacture and testing meets the requirements of both CE mark and FDA submissions.
* Work with the organisation's suppliers to ensure the products' process validations and risk management files are to the standard of regulatory submissions.
Requirements:
To succeed in this role, you will need:
* Bachelor's degree in Engineering or Science with a minimum of 3 years of regulatory experience in the medical device industry.
* Regulatory certifications in EU MDR and US FDA desirable.
* Thorough understanding and knowledge of ISO 13485, ISO 14971, EU MDR, UK MDR, MDSAP, US 21 CFR 820 and supporting standards.
* Proven track record with the ability to successfully manage projects to deadlines.
* Experience working directly with regulatory agencies.
What We Offer:
As a Regulatory Affairs Specialist, you will have the opportunity to work in a dynamic environment and contribute to the success of our company. We offer competitive benefits, including a bonus scheme, pension, and excellent opportunities for career development.
If you are a motivated and experienced professional looking for a new challenge, please forward your application to us.