Regulatory Compliance Specialist
This role requires a proactive professional with a strong willingness to contribute effectively. Excellent organizational skills, ability to balance short-term and long-term priorities, and strong multi-tasking abilities are essential.
* Collaborate with the Quality Assurance Manager to ensure the effectiveness of the Quality Management System in line with regulatory requirements.
* Manage daily regulatory activities and oversee multiple projects related to product compliance enhancements.
* Work closely with the Quality Assurance Manager for notified body audits and other regulatory inspections as required.
* Assist in transitioning from MDD to MDR within the organization.
* Support the team in ensuring that product development and testing meet CE mark and FDA submission requirements.
* Work with suppliers to ensure products' process validations and risk management files comply with regulatory submissions.
* Provide strategic regulatory insight to team members regarding product development plans.
* Collaborate with the Commercial Team/Distributors to ensure country-specific registration activities are understood and addressed.
* Maintain day-to-day activities of Post-Market Surveillance with the Quality Assurance Manager, including:
1. Logging customer complaints and adverse events, coordinating investigations between customers and contract manufacturing sites, and addressing initiatives to test, change, and improve products as needed.
2. Monitoring global regulatory trends and requirements impacting product development and commercialization, advising colleagues and external partners to ensure compliance.
3. Evaluating manufacturing and labeling changes, promotional materials for regulatory impact, and ensuring compliance with applicable regulations.
4. Maintaining awareness of global regulatory legislation and assessing its impact on business and product development programs.
5. Staying up-to-date with changes in domestic and international regulations and guidelines, advising key staff on compliance/non-compliance with current international regulations, policies, and EC directives.
6. Supporting the team with CE mark Submissions/S Significant Changes and Notified Body interactions.
7. Supporting the team with 510(k) regulatory filings and subsequent FDA correspondence on submissions.
8. Performing other regulatory-related duties as required.
A bachelor's degree in engineering or science, minimum of 4 years of experience in a medical device company, and regulatory certifications in MDR are desirable. A minimum of 4 years of experience in the medical device industry is required. Strong understanding and knowledge of ISO 13485, ISO 14971, MDD & MDR are necessary. Proven track record of successfully managing projects to deadlines, experience working directly with regulatory agencies, and excellent problem-solving and communication skills are essential.