Job Summary:
We are seeking a highly skilled Regulatory Associate to join our team. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and standards in the medical device industry.
About Us:
We are an innovative company disrupting paediatric ENT care with a streamlined, in-office ear-tube insertion device. We have scaled from Irish clinical success to U.S. regulatory approval and global roll-out under a multinational company. With a strong IP portfolio, seasoned leadership, and growing market presence, we're well-positioned to change the standard of care in paediatric ear surgery.
Key Responsibilities:
* Support day-to-day regulatory activities and handle multiple projects related to regulatory compliance enhancements.
* Assist in implementing MDSAP within the organization.
* Support the team in obtaining/retaining country-specific regulatory registrations globally.
* Work with the commercial team/distributors to ensure country-specific registration activities are understood and addressed.
* Collaborate with interdisciplinary team members to ensure the effectiveness of the quality management system (QMS) to regulations.
* Work closely with QA for internal and external audits, including notified body audits as required.
* Support the wider team in ensuring product manufacture and testing meets CE mark and FDA submission requirements.
* Partner with suppliers to ensure products' process validations and risk management files meet regulatory submission standards.
* Provide strategic regulatory insight to team members on product development plans.
* Maintain post-market surveillance activities, including logging customer complaints and adverse events, coordinating investigations, and addressing initiatives to test, change, and improve products as needed.
* Monitor global regulatory trends and advise colleagues and partners to ensure compliance.
* Evaluate manufacturing and labeling changes, and promotional materials for regulatory impact and compliance.
* Maintain awareness of global regulatory legislation and assess its impact on business and product development programs.
* Keep abreast of changes in domestic and international regulations and guidelines, advising key staff on compliance/non-compliance with current international regulations.
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 CFR 820, and supporting standards.
* Proven track record of successfully managing projects to deadlines.
* Experience working directly with regulatory agencies.
* Strong ability to manage critical projects as part of an interdisciplinary team.
* Excellent problem-solving and communication skills.
* Self-motivated, highly organized, and detail-oriented individual with excellent oral and written communication skills.
* Able to work as part of a cross-functional team and thrive in a fast-paced environment.