Regulatory Affairs Professional
Key Responsibilities include working closely with the QA Manager to ensure the effectiveness of the Quality Management System to regulations.
* Managing day-to-day regulatory activities and handling multiple projects related to product and compliance enhancements.
* Working closely with the QA Manager for notified body audits and other audits as required.
* Work with suppliers to ensure the products' process validations and risk management files are up to the standard of regulatory submissions.
* Provide strategic regulatory insight to team members regarding product development plans.
* Collaborate with the Commercial Team and Distributors, to ensure country-specific registration activities are understood and appropriately addressed.
* Maintain the day-to-day activities of Post Market Surveillance, including logging customer complaints and adverse events, coordinating investigations between complainants and contract manufacturing sites, and addressing initiatives to test, change, and improve the products as required.
* Monitor global regulatory trends and requirements impacting the development and commercialization of products and advise colleagues and external partners to ensure compliance.
* Evaluate manufacturing and labeling changes, and promotional materials for regulatory impact and to ensure compliance with applicable regulations.
Requirements:
* A Bachelor's degree in engineering or science, with a minimum of 4 years of experience in a medical device company.
* Regulatory certifications in MDR are desirable.
* At least 4 years of experience in the medical device industry.
* Thorough understanding and knowledge of ISO standards, such as ISO 13485 and ISO 14971, MDD & MDR.
* Proven track record in 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.
* Must be self-motivated, highly organized, and detail-oriented.
* Excellent oral and written communication skills.
* Ability to work as part of a cross-functional team.
* Thrives in a fast-paced environment.
Industry: Medical Device
Location: Cork
Country Code: IE
Language: en