The Regulatory Affairs Engineer will be responsible for ensuring compliance with global regulatory requirements for medical device products intended for export. This role involves working closely with cross-functional teams to prepare and submit regulatory documentation, maintain compliance with international standards, and support the successful entry of products into new markets.
KEY TASKS & RESPONSIBILITIES
1. Develop and implement regulatory strategies for the export of medical devices to various international markets, including but not limited to the EU, LatAm, Brazil, Canada and Asia-Pacific regions.
2. Ensure compliance with country-specific regulatory requirements, including product registration, labelling, and documentation.
3. Prepare and submit regulatory filings and other international submissions as required.
4. Manage and keep up to date the registration tracker file.
5. Maintain and update regulatory documentation, including Design Dossiers, Technical Files, and Declarations of Conformity.
6. Collaborate with the Quality Assurance team to ensure that products meet global quality standards and regulatory requirements.
7. Monitor and interpret regulatory changes and updates in export markets, and communicate these changes to relevant stakeholders.
8. Provide regulatory guidance during the design and development of new products, ensuring that export considerations are integrated early in the process.
9. Support the development of product labelling and promotional materials to ensure compliance with export market regulations.
10. Participate in the risk management process according to the applicable standard (ISO 14971).
11. Conduct regulatory risk assessments for new and existing products intended for export, identifying potential compliance issues and participate in the development of a mitigation plan.
12. Participate in internal audits and support external audits by regulatory authorities and notified bodies (ISO 13485, MDSAP among others).
13. Support compliance and change control management and act as backup when necessary.
14. Stay current with global regulatory trends and share insights with the broader team to support continuous improvement.
15. Lead and manage projects within the scope of activities, working with cross-functional teams, as may be required.
EDUCATION/LANGUAGES
1. Bachelor’s or Master’s degree in Regulatory Affairs, Biomedical Engineering, Life Sciences, or a related field.
2. Fluency in English.
PROFESSIONAL SKILLS & EXPERIENCE
1. Minimum of 3-5 years of experience in regulatory affairs within the Medtech industry, preferably with a focus on export regulations.
2. Excellent understanding of ISO standards (13485,…) ICH, GMP, GDP, GCP, FDA (21CFR’s parts 210, 211 & 820, MDR, Healthcare compliance and applicable regulations and industry standards).
3. Experience with regulatory submissions for international markets, including the preparation of Technical Files and product registrations.
4. Excellent computer skills.
PERSONAL SKILLS & COMPETENCIES
1. Strong ethics, creativity and problem-solving abilities.
2. Proactive and ability to initiate and self-start projects.
3. Positive, flexible and resilient. Ability to handle ambiguity & changes.
4. Strong attention to detail with excellent organisational and project management skills.
5. Strong communication and presentation skills.
6. Strong team player and ability to work across functions.
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