Manager - DQA/Compliance/Regulatory - Medical Devices

Manager - DQA, Compliance, Regulatory - Medical Devices

Job Description : The role is a people management role in the domain of DQA, Compliance and Regulatory responsible for a team of 10-12 people. It is a leadership role with a global interface based out of India.

Client Details : Our client is one of the leading medical devices manufacturers with a global presence.

Description :

- Responsible for leading product and process quality and regulatory in the development of products.

- Lead guidance activities to NPD teams to ensure compliance to the company's quality system and external standards.

- Manage regulatory filings and submissions to meet the quality and standards/requirements set by US FDA, EU Notified Body and other Health Authorities.

- Act as Regulatory Affairs Management designate on various cross-functional review boards to provide strategic input and technical guidance on regulatory requirements to development teams

- Lead risk management activities for products and drive statistical techniques to drive appropriate risk management activities and prioritisation of issues.

Profile :
- 15+ years' of experience with a product OEM in the medical devices space

- Proven expertise in medical device product development lifecycle, including risk management and design/process verification and validation.

- Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.)

- Demonstrated ability to effectively work cross-functionally with other departments, including Product Development, Clinical Affairs, Marketing

- Proven demonstration of written, verbal, listening, communication, and team-building skills.

Job Offer : A leadership people management role with a leading organisation with great culture.

Contact - Gourab Ray - +91 124 452 5454

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