Head - Quality and Regulatory

Job Title: Head - Quality and Regulatory

Summary:

We are seeking an experienced and highly skilled individual to join our team as the Head of Quality and Regulatory Affairs. The successful candidate will have a minimum of 5-10 years of experience in the Quality and Regulatory Affairs department of a medical devices or diagnostics company. As the Head of Quality and Regulatory, you will be responsible for ensuring compliance with all quality standards and managing domestic and international regulatory filings within our organization. You will also be responsible for developing and implementing quality control processes and procedures to ensure the highest level of product quality and customer satisfaction.

Roles and Responsibilities:

- Develop and implement quality control processes and procedures to ensure compliance with all ISO 13485 and other relevant regulatory standards.

- Oversee the quality assurance team and provide guidance and support to ensure the highest level of product quality.

- Collaborate with cross-functional teams to ensure quality standards are met throughout the product development lifecycle.

- Conduct regular audits and inspections to identify areas for improvement and implement corrective actions as necessary.

- Stay up-to-date with industry regulations and standards and ensure that our organization is compliant at all times.

- Manage relationships with regulatory agencies such as CDSCO and ensure timely submission of all required documentation and reports.

- Provide training and support to employees on quality control processes and procedures.

- Lead and participate in quality improvement initiatives to drive continuous improvement throughout the organization.

Qualifications:

- Bachelors degree in a relevant scientific/engineering discipline. Candidates with an R&D background with experience of QMS filings for new product development will be preferred.

- Minimum of 5-10 years of experience in the Quality and Regulatory Affairs department, preferably in a leadership role.

- Strong knowledge of quality control processes and regulatory requirements.

- Excellent communication and leadership skills.

- Attention to detail and strong analytical skills.

- Ability to work effectively in a fast-paced and dynamic environment.

- Experience in In Vitro Diagnostics or medical device industry is preferred.

- Certification in quality management or regulatory affairs is a plus.

If you are a highly motivated individual with a passion for quality and regulatory compliance, we encourage you to apply for this exciting opportunity.