Regulatory Affairs Specialist
6 hours ago
Regulatory Affairs Specialist (Remote/Hybrid)
Our client, a high potential start-up medical device company, currently seeks a Regulatory Affairs Specialist to join their team. Reporting to the Clinical and Regulatory Affairs Manager, the Regulatory Specialist will be responsible for helping with compliance to standards, regulatory submissions, and annual reporting to the notified body and FDA. The Regulatory Affairs Specialist must have a working knowledge of medical device regulatory requirements and standard practices in the medical device industry. This position requires an enthusiastic self-starter with a willingness to be a “hands-on” contributor. Excellent organisational skills, the ability to balance immediate vs. long-term priorities, and strong multi-tasking skills are a necessity. An ability to work in a flexible and small entrepreneurial environment is essential, and there is an excellent package available for the right candidate.
Role/Responsibilities:
- Work closely with the QA Manager to ensure the effectiveness of the QMS to regulations.
- Manage day-to-day regulatory activities as well as handle multiple projects related to product and compliance enhancements.
- Work closely with the QA Manager for notified body audits and other audits as required.
- Assist in the migration from MDD to MDR within the organisation.
- Support the wider team to ensure product manufacture and testing meet the requirements of both CE mark and FDA submissions.
- Work with the organisation’s suppliers to ensure the products’ process validations and risk management files meet the standards of regulatory submissions.
- Provide strategic regulatory insight to team members regarding product development plans.
- Work with the Commercial Team / Distributors to ensure country-specific registration activities are understood and appropriately addressed.
- Maintain with the QA Manager the day-to-day activities of Post Market Surveillance, including, but not limited to:
- 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.
- Monitoring global regulatory trends and requirements impacting the development and commercialization of products and advising colleagues and external partners to ensure compliance.
- Evaluating manufacturing and labelling changes and promotional materials for regulatory impact and ensuring compliance with applicable regulations.
- Maintaining awareness of global regulatory legislation and assessing its impact on business and product development programs.
- Keeping abreast of changes in domestic and international regulations and guidelines and advising key staff of compliance/non-compliance with current international regulations, policies, and EC directives.
- Supporting the team with CE mark submissions/significant changes and notified body interactions.
- Supporting the team with the preparation of 510(k) regulatory filings and subsequent FDA correspondence on submissions.
- Carrying out other regulatory-related duties as required.
Skills/Experience:
- 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.
- Must be self-motivated, highly organised, and detail-oriented.
- Excellent oral and written communication skills.
- Must be able to work as part of a cross-functional team.
- Thrives to work in a fast-paced/entrepreneurial environment.
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