Assistant Manager Regulatory Affairs - Surat

Job description

Duties and Responsibilities

1. Write, analyze, and edit technical documents to support country-specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents. Work with other departments and communicate the submission requirements when documents are needed for regulatory submission.

2. Maintain regulatory files. Maintain and update regulatory authorizations, assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes and annual reports. Support approval in other regions as required.

3. Assist in preparing responses to regulatory authorities questions within assigned timelines.

4. Stay abreast of regulatory procedures, guidance documents, standards, and changes in the regulatory climate.

5. Review product labels and review promotional material for compliance with applicable regulations and technical standards. Maintain product UDI listings in country-specific databases.

7. Support external regulatory agency audits, providing regulatory input to minimize the potential for findings of non-compliance.

8. Assess and document the regulatory impact of product design changes in jurisdictions where the product is licensed. Participate in design projects as an independent reviewer.

9. Review and approve product change orders and deviations, considering the regulatory impact of proposed changes.

10. Assist in fulfilling requirements of the Person Responsible for Regulatory Compliance under the EU

11. Maintain QMS procedures related to regulatory responsibilities, product licensing, and regulatory reporting.

12. Participate in the internal audit program., Support other projects, as required.

Key Attributes (experience, skills, and technical knowledge)

• Bachelor's degree, related scientific discipline, or equivalent. A higher degree will be an advantage.
• Documented training on current medical device standards and regulations is an asset (e.g. MDSAP, EU MDR, ISO 13485, etc.)
• Scientific knowledge must be able to digest complex data while keeping the big picture through good analytical skills.
• Excellent written and verbal communication skills with the ability to listen, articulate and advocate.
• Proactive, high performance, result-oriented and manage projects with ethical integrity.
• Technical system skills (e.g., MS office applications, databases, efficient online research) ▪ Manage multiple projects and deadlines.
• Ability to identify compliance risks and escalate when necessary.
• Demonstrate both creative and critical thinking skills.