Senior RA Specialist

Our client is a fast-growing and stable Medical Devices MNC, with a strong product pipeline

Regulatory Strategy: Develop and implement regulatory strategies to support the registration and approval of medical devices in domestic and international markets.

Regulatory Submissions: Prepare, review, and submit regulatory dossiers, including 510(k)s, premarket approval applications (PMA), CE Mark applications, and other submissions, ensuring accuracy and completeness.

Product Classification: Determine the appropriate regulatory pathway and classification for new and existing medical devices.

Labeling and Packaging: Review and approve product labeling, packaging, and marketing materials to ensure compliance with regulatory requirements.

Post-Market Surveillance:Support post-market surveillance activities, including adverse event reporting, field actions, and product recalls, as necessary.

Regulatory Intelligence: Stay informed about changes in medical device regulations, guidelines, and standards, and communicate relevant updates to the organization.

Cross-Functional Collaboration: Collaborate with R&D, Quality Assurance, Clinical Affairs, and Marketing teams to provide regulatory guidance and support throughout the product lifecycle.

Regulatory Audits:Prepare for and participate in regulatory agency audits, inspections, and notified body assessments.

Training and Guidance: Provide training and mentorship to junior members of the regulatory affairs team and other relevant departments.

(Registration Number: 199603098R | Company License Number : 16S8067 Consultant License Number R2198025.)