Regulatory Affairs Consultant

Regulatory Affairs Specialist (Neuromodulation)

Our client is a leading innovator in the field of medical devices, specializing in neuromodulation, software-driven technologies, and implantable Class III medical devices. We are committed to improving the lives of patients worldwide through cutting-edge healthcare solutions. Our Regulatory Affairs team plays a pivotal role in ensuring our products meet global regulatory requirements, and we are seeking an experienced Regulatory Affairs Specialist to join our dynamic team.

Job Summary:

As a Medical Device Regulatory Affairs Specialist you will be responsible for managing international registrations and change assessments related to our neuromodulation and implantable Class III medical devices. Your primary focus will be on ensuring compliance with global regulatory standards and guiding product development teams to meet these requirements. You will leverage your expertise in regulatory affairs to facilitate product approvals and maintain regulatory compliance.

Key Responsibilities:

1. International Regulatory Submissions: Prepare and submit regulatory applications for product approvals in international markets, ensuring compliance with regional regulations, including but not limited to FDA, EU MDR, and other global authorities.
2. Change Assessments: Assess the impact of changes to existing products and manufacturing processes on regulatory submissions, and update regulatory documentation as needed.
3. Neuromodulation and Implantable Devices: Specialize in the regulatory affairs aspects of neuromodulation and implantable Class III medical devices, staying up-to-date with industry trends and regulatory changes specific to these product categories.
4. Regulatory Strategy: Develop and execute regulatory strategies for product development projects, collaborating with cross-functional teams to achieve regulatory milestones.
5. Documentation Management: Maintain regulatory files, ensuring completeness and accuracy, and organize records for audits and inspections.
6. Regulatory Compliance: Monitor and track changes in global regulations affecting medical devices, and proactively communicate updates and potential impacts to internal stakeholders.
7. Risk Assessment: Conduct risk assessments related to regulatory compliance and provide guidance on risk mitigation strategies.
8. Cross-Functional Collaboration: Collaborate with R&D, Quality Assurance, Clinical Affairs, and other departments to ensure regulatory requirements are integrated into product development processes.
9. Audit Support: Assist in the preparation and support of regulatory agency audits and inspections.