Regulatory Specialist Role
About the Job:
This position offers an exciting opportunity to be at the forefront of innovation and contribute significantly to our company's success. You will play a crucial role in ensuring our products and services comply with all relevant regulations and standards.
Key Responsibilities:
* Develop and execute regulatory strategies for product registration, approval, and compliance.
* Manage day-to-day regulatory activities, handle multiple projects related to regulatory compliance enhancements, and manage regulatory submissions.
* Support the team to obtain / retain country-specific regulatory registrations on a global basis.
* Implement MDSAP within the organization and ensure compliance with national and international regulatory requirements and quality standards.
* Identify and assess potential regulatory risks and propose/implement effective mitigation strategies.
* Collaborate 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.
* Contribute to maintaining the highest level of quality within the organization by assessing overall risk profiles and creating programs/tools to mitigate potential risks.
* Manage Post Market Surveillance, including customer complaints, adverse events, investigations, and initiatives to test, change, and improve products 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 are 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 is essential.
* Strong ability to manage critical projects as part of an interdisciplinary team.