Gm Quality Assurance and Regulatory Affairs

Planet Innovation (PI) is an award winning Healthtech Innovation and Commercialization company, and we work on some of the most advanced technology in the world. We have our own portfolio of businesses, and also partner with world-leading organizations to help them create game-changing innovations to grow their business. Our clients include some of the world's top medical device and healthcare companies, as well as some of the world's most exciting start-ups.

Creating great products and winning awards is all down to our team. Planet Innovation has over 500 of the brightest and most passionate people on Earth, and we are looking for more.

We are looking for a Quality Assurance and Regulatory Affairs (QA/RA) General Manager (GM) with strong leadership and communication skills to join our Leadership Team leading the global QA/RA business unit.

**QA/RA at PI**

Planet Innovation has a rigorous quality management system that is certified to ISO 9001 and ISO 13485:2016 for the development and manufacture of medical devices. We have a dedicated QA/RA department and a comprehensive quality system including a QA manual, formal quality procedures for all major components of the development process, and many templates and guidelines for developing procedures and processes that we call on during every project.

We have extensive experience developing biomedical devices for regulated US and European markets, including FDA QSR 820.30 Design Controls, and we manufacture medical products for use in various regulatory jurisdictions, including the US (FDA), Europe (CE), Health Canada, and APAC region. These include low-risk devices to higher-risk IVDs and medical devices.

**The Role**

The Quality Assurance and Regulatory Affairs GM role is the head of the global QA/RA business unit and is responsible for leading a quality management team and ensuring overall management and company compliance of relevant regulatory requirements and ensuring that its certifications and licenses are always maintained.

This QA/RA GM is the Management Representative as defined by ISO 13485. They have overall responsibility for the management of the Quality System to ensure ongoing compliance with current ISO13485 and 21 CFR Part 820 requirements as well as various other in-country regulatory requirements. The QA/RA GM also ensures overall General Data Protection Regulation (GDPR) complaints for all of PI’s personal data processing activities.

The QA/RA GM reports to the Chief Operating Officer and will be working in close collaboration with the Global VP of Manufacturing and the PI leadership team.

**The Accountabilities**:

- Provide QA/RA leadership to the global QA/RA business unit
- Take a lead role in liaising and cultivating relationships with external parties in relation to the Quality and Regulatory management systems and be the first point of contact for all issues relating to external regulatory and customer audits, inquiries, and complaints.
- Responsible for people leading, building, and developing the global QA/RA team including ongoing management, coaching and development of team members, and identification and recruitment of new team members.
- Be responsible for the registration/inclusion of all devices with the appropriate regulatory authorities in a timely manner and for implementing an effective post-marketing surveillance system compliant with the regulatory requirements.
- Monitor and regularly report on the effectiveness of the Quality and Regulatory systems to the PI Leadership team and take a leadership role in the identification of areas for improvement and the development and implementation of improvement strategies and initiatives.
- Work with relevant business unit General Managers to develop, publish, train and implement process procedures, work instructions, systems, and forms according to the agreed internal project timetable.
- Inform and provide expert advice to PI regarding the processing of personal data and GDPR, including monitoring, providing, and maintaining necessary documentation, and training to comply with the GDPR.

**The Typical Experiences**:

- 10+ years of QA/RA management experience, with 5+ years of commercial and people leadership experience.
- Expert knowledge in medical device regulations and quality management standards such as 21 CFR 820, MDR/MDD, IVDR/IVDD, ISO 13485, ISO 14971, and IEC 62304.
- Demonstrated experience in taking multiple products to market including regulatory approval.
- B2B experience, including managing B2B customer relationships in a manufacturing and product development environment, ideally with international experience.
- Demonstrated experience in managing quality teams and influencing business decisions to align to quality standards.
- Experience with customers and clients in a medical device environment is highly regarded
- Degree qualified in a Science or Engineering Discipline. Business qualification (i.e. MBA) desirable.
- Certificate in Lead Auditing d