Job Title: Regulatory Affairs Specialist
We are seeking a highly skilled Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for ensuring compliance with regulatory standards, preparing and submitting regulatory documents, and maintaining awareness of global regulatory trends and requirements.
Key Responsibilities:
* Work closely with the QA Manager to ensure the effectiveness of the Quality Management System (QMS) in meeting regulatory requirements.
* Manage day-to-day regulatory activities, including handling multiple projects related to product and compliance enhancements.
* Collaborate with the QA Manager for notified body audits and other audits as required.
* Assist in the migration from Medical Device Directive (MDD) to Medical Device Regulation (MDR).
* Support the team in ensuring product manufacture and testing meets the requirements for CE mark and FDA submissions.
* Work with suppliers to ensure products' process validations and risk management files meet regulatory submission standards.
* Provide strategic regulatory insight to team members regarding product development plans.
* Maintain day-to-day activities of Post Market Surveillance, including logging customer complaints and adverse events, coordinating investigations, and addressing initiatives to test, change, and improve products as required.
Requirements:
* Bachelor's degree in engineering or science with a minimum of 4 years of experience in a medical device company.
* Regulatory certifications in MDR desirable.
* A minimum of 4 years of experience in the medical device industry.
* Thorough understanding and knowledge of ISO 13485 and ISO 14971, MDD & MDR.
* 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.
* Excellent oral and written communication skills.
* Able to work as part of a cross-functional team.
About the Role:
This is a fantastic opportunity to join a dynamic and entrepreneurial environment. If you have a passion for regulatory affairs and a proven track record of delivering results, we would love to hear from you.