The Head of Quality and Regulatory Affairs is responsible for the overall quality and regulatory compliance of the company's medical devices. This includes ensuring that all products meet applicable regulations, that quality systems are in place and effective, and that the company has a strong regulatory compliance culture.

Key responsibilities

• Lead the development and implementation of the company's quality and regulatory policies and procedures as per ISO13485 and applicable standards

• Develop regulatory strategies for US, Canada, EU, India markets

• Oversee the quality assurance and regulatory affairs activities of the company, including product development, manufacturing, and distribution

• Ensure that all products meet applicable regulations, such as the FDA's Quality System Regulation (QSR), the EU's Medical Device Regulator (MDR)

• Represent the company to regulatory agencies, such as the FDA and the European Commission

• Build and maintain relationships with key stakeholders, such as customers, suppliers, and regulatory agencies

• Manage the company's regulatory compliance risk

• Provide leadership and direction to the quality and regulatory affairs team

Qualifications

• Bachelors / Masters degree in a relevant field, such as engineering, science, or business

• 10+ years of experience in quality and regulatory affairs in the medical device industry

• Strong understanding of applicable regulations, such as the QSR and the MDR

• Proven track record of leading and managing quality and regulatory affairs teams

• Excellent communication and interpersonal skills

• Ability to work independently and as part of a team

• Experience with the management of risk

• Experience with the use of quality management tools and techniques

• Experience with the development and implementation of training programs

• Experience with the management of change
  

Person-profile

• Good leadership skills and ability to create highly motivated teams

• Self-driven, energetic, and ambitious

• Excellent communication (written and verbal) and presentation skills, with leadership qualities

• Exceptional organizational skills and ability to prioritize competing priorities, along with strong reasoning and problem-solving abilities

• High level of integrity

• Strong track record of delivering results

• Data-driven decision-making mindset

• Proficiency in English

Estimated travel activity:

10 days per quarter