Job Title: Regulatory Affairs Expert
This role is a fantastic opportunity to join our company as we continue to innovate and push the boundaries of medical device technology.
About the Role:
We are seeking a highly skilled Regulatory Affairs Expert to lead our regulatory strategy and ensure compliance with all relevant regulations and standards. As a key member of our team, you will be responsible for developing and executing regulatory strategies, managing submissions, and maintaining compliance with evolving regulatory requirements.
Responsibilities:
* Develop and execute regulatory strategies for product registration, approval, and compliance.
* Manage day-to-day regulatory activities and handle multiple projects related to regulatory compliance enhancements.
* Management of regulatory submissions, including preparation, maintenance, review, and submission of regulatory documents and applications to health authorities.
* Support the team in obtaining/retaining country-specific regulatory registrations on a global basis.
* Implement MDSAP within the organisation.
* Monitor and ensure compliance with national and international regulatory requirements and quality standards.
* Identify and assess potential regulatory risks and propose/implement effective mitigation strategies.
* Work closely with QA, R&D, Operations, Clinical Affairs, and other departments to integrate regulatory requirements into QMS and product development processes.
* Stay current with changing regulations, guidelines, and industry trends.
* Maintain the highest level of quality within the organisation by assessing overall risk profiles and creating programs/tools to mitigate potential risk.
* Perform post-market surveillance activities, including logging customer complaints and adverse events, coordinating investigations, and addressing initiatives to test/change/improve products as required.
* Manage CE mark submissions, significant change notifications, and Notified Body interactions.
* Support the team with international regulatory filing, including 510(k) submissions and subsequent FDA correspondence.
* Review/approve public-facing materials for regulatory compliance.
* Carry out other regulatory-related duties as required.
Requirements:
* Bachelor's degree in Engineering or Science with a minimum of 6 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, 21 CFR 820 and supporting standards.
* Proven track record with the ability to successfully manage projects to deadlines.
* Experience working directly with regulatory agencies.
* Strong ability to manage critical projects as part of an interdisciplinary team.
What We Offer:
This is an exciting opportunity to be at the forefront of innovation and make a significant contribution to our company's success. You will have the chance to work with a talented team and develop your skills and expertise in a rapidly evolving industry.