Head of Quality & Regulatory Affairs
Oivi is an ambitious and young medtech company developing a technology to overcome a huge challenge that impacts the lives of millions of people with diabetes.
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
- Department
- R & D
- Role
- Head of Quality & Regulatory Affairs
- Locations
- India/BLR Office, Oslo
- Remote status
- Hybrid Remote
About Oivi
We are a young and dynamic startup that is working hard to bring eye screening to everyone.
We are hiring, so please reach out to us if you believe in our mission and think you are the right fit!
Head of Quality & Regulatory Affairs
Oivi is an ambitious and young medtech company developing a technology to overcome a huge challenge that impacts the lives of millions of people with diabetes.
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