Regulatory Compliance Specialist
Overview:
* Spearhead regulatory submissions worldwide to ensure global compliance.
* Manage annual reporting to notified bodies and competent authorities.
* Maintain standards and regulations compliance within the organization.
Responsibilities:
* Support daily regulatory activities and handle multiple projects related to regulatory compliance enhancements.
* Implement MDSAP within the organization.
* Collaborate with the Commercial Team/Distributors to understand country-specific registration activities.
* Work closely with interdisciplinary team members to ensure the effectiveness of the QMS to regulations.
* Coordinate internal and external audits, including notified body audits as required.
* Ensure product manufacture and testing meets CE mark and FDA submission requirements.
* Work with suppliers to validate process and risk management files for regulatory submissions.
* Provide strategic regulatory insight to team members regarding product development plans.
Post Market Surveillance:
* Log customer complaints and adverse events.
* Coordinate investigations between complainants and contract manufacturing sites.
* Regulatory trending and reporting activities as required.
* Monitor global regulatory trends and requirements impacting product development and commercialization.
* Evaluate manufacturing and labelling changes for regulatory impact.
* Assess promotional materials for regulatory compliance.
* Stay up-to-date with domestic and international regulations and guidelines.
Requirements:
* Bachelor's degree in Engineering or Science.
* Minimum 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 with project management skills.
* Experience working directly with regulatory agencies.