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Job Description
Regulatory Affairs Specialist sought for a high potential start-up medical device company. The ideal candidate will have a working knowledge of medical device regulatory requirements and standard practices in the medical device industry.
Key responsibilities include:
- Ensuring the effectiveness of the Quality Management System (QMS) to regulations.
- Managing day-to-day regulatory activities and handling multiple projects related to product and compliance enhancements.
- Coordinating with the QA Manager for notified body audits and other audits as required.
- Assisting in the migration from MDD to MDR within the organisation.
- Supporting the team to ensure product manufacture and testing meet the requirements of both CE mark and FDA submissions.
- Working with suppliers to ensure products' process validations and risk management files meet regulatory standards.
- Providing strategic regulatory insight to team members regarding product development plans.
- Coordinating with the Commercial Team / Distributors to ensure country-specific registration activities are understood and addressed.
- Maintaining Post Market Surveillance activities, including logging customer complaints and adverse events.
- Monitoring global regulatory trends and requirements impacting product development and commercialization.
- Evaluating manufacturing and labelling changes for regulatory impact.
- Maintaining awareness of global regulatory legislation and assessing its impact on business and product development programs.
- Supporting the team with CE mark submissions and notified body interactions.
- Supporting the team with 510(k) regulatory filings and subsequent FDA correspondence.
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 with the ability to successfully manage 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 organised, and detail-oriented.
- Excellent oral and written communication skills.
- Ability to work as part of a cross-functional team.