Halma - Associate - Regulatory Affairs (4-6 yrs)

Responsibilities:

- Communicates with regulatory authorities and/or distributors to prepare and submit documentation for marketing approval in ASEAN, Middle East and GCC Nations.

- Co-ordinates with distributors for Medical Device registration in other parts of the world as and when required.

- Performs research, distribution, storage, tracking, and retrieval of relevant information/documents pertinent to the regulatory registrations and submissions.

- Authors, reviews, and publishes paper and electronic submissions and communicates with regulatory authorities and government agencies.

- Provides regulatory information and guidance for proposed product claims/labelling.

- Identifies the need for new regulatory procedures, Operating Procedures, and participates in development and implementation.

- Helps train stakeholders on current and new quality and regulatory requirements to ensure organization-wide compliance.

- Assists other departments in the development of Operating Procedures to ensure regulatory compliance.

- Reviews proposed product changes for impact on regulatory status of the product.

- Prepare/record changes to controlled documents including formatting, review and confirm changes with relevant departments, prepare training material, and coordinate with users to ensure electronic document processing is complete and document control is maintained and effective.

- Performs other duties that are reasonably assigned.

Critical Success factors:

- Identify most favorable regulatory routes and pathways to ensure faster and cost-effective registrations.

- Excellent written and verbal communication skills, and able to effectively manage regulatory authority or auditor's intent.

- Complies with regulatory requirements of the ASEAN, Middle East and GCC Nations and any other regulations of target markets.

- Be aware of recent and future regulatory trends and plan accordingly to ensure Volk's compliance.

- Ability to develop and evaluate risk of potential regulatory strategies for new and modified products by performing research and analysis in both new and sustaining markets.

- Must show appropriate judgement and logic to show improvements to the quality system, document control, and regulatory complianc

Experience:

- Minimum 4 years of experience.

- Comprehensive understanding of applicable regulations of ASEAN, Middle East and GCC Nations