Regulatory Compliance Specialist
This is a unique opportunity to join an innovative med-tech spin-out, disrupting paediatric ENT care with a streamlined, in-office ear-tube insertion device. We've scaled from Irish clinical success to U.S. regulatory approval and global roll-out under a multinational company.
* You will be responsible for regulatory submissions worldwide, annual reporting to the notified body and competent authorities, and maintaining compliance to standards and regulations.
* Support day-to-day regulatory activities as well as handling multiple projects related to regulatory compliance enhancements.
* Assist in the implementation of MDSAP within the organisation.
* Work closely with interdisciplinary team members to ensure the effectiveness of the QMS to regulations.
* Work closely with QA for internal and external audits, including notified body audits as required.
* Support the wider team to ensuring product manufacture and testing meets the requirements of both CE mark and FDA submissions.
Key Responsibilities:
* Support day-to-day regulatory activities as well as handling 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 interdisciplinary team members to ensure the effectiveness of the QMS to regulations.
* Work closely with QA for internal and external audits, including notified body audits as required.
* Support the wider team to ensuring product manufacture and testing meets the requirements of both CE mark and FDA submissions.
* Monitor global regulatory trends and requirements impacting the development and commercialization of products and advise colleagues and external partners to ensure compliance.
* Evaluating manufacturing and labelling changes, and promotional materials for regulatory impact and to ensure compliance with applicable regulations
* Maintaining awareness of global regulatory legislation and assess its impact on business and product development programs
Requirements:
* 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 CRF 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