V&V Manager

About the role

A Verification and Validation Manager plays a crucial role in ensuring that the products meet regulatory and quality standards.

Responsibilities:

· Develop and implement V&V strategies for new and existing products.

· Lead V&V teams in creating test plans, protocols, and reports.

· Ensure compliance with regulatory standards throughout the V&V process.

· Collaborate with cross-functional teams to integrate V&V activities into the product

development lifecycle.

· Conduct risk assessments and implement risk management processes.

· Oversee the execution of verification and validation testing, ensuring accuracy and

completeness.

· Guide testing methodologies and ensure alignment with best practices.

· Review and approve V&V documentation for regulatory submissions.

· Participate in audits and inspections related to V&V activities.

Professional skills Requirements:

· Bachelor’s degree in biomedical or another related Degree

· 2 years of Experience in a management role, preferably as V&V Manager

· Strong understanding of regulatory requirements and standards for medical devices to ensure

compliance throughout the V&V process.

· Ability to lead and manage V&V projects, including planning, execution, and documentation.

· Expertise in identifying and assessing risks associated with medical devices and implementing

risk management processes throughout the product lifecycle.

· In-depth knowledge of testing methodologies, including protocol development, execution,

and validation of results.

Attributes:

· Strong written and verbal communication skills for preparing comprehensive V&V reports

documentation and communicating with regulatory bodies.