About the Role
As a Regulatory Affairs and Quality Assurance (RAQA) Manager, you will utilise your extensive technical expertise to ensure that the company complies with regulatory requirements in all applicable global regions and supports the company to meet the required quality standards and objectives in all business areas.
We're growing fast! You will be joining us at an exciting stage of company growth therefore we’re looking for a highly motivated and talented Regulatory Affairs and Quality Assurance (RAQA) Manager to join our team. You'll work alongside a team of experienced professionals who are passionate about using technology to improve healthcare.
We are self-driven and inspire others to continue to build on existing skills by giving you the tools you need to do so. If you're looking for a challenging and exciting opportunity to apply your expertise to the development of life-saving medical technology, ZiO Health is the place for you.
Responsibilities
- Lead, implement and maintain the Quality Management System in line with ISO 13485 requirements throughout the organization.
- Implement and oversee the company's Risk Management processes in line with ISO 14971 requirements.
- Define quality strategy and establish, implement and maintain processes. Set objectives, measure achievement of goals and support the business in achieving its overall strategic goals.
- Manage all external audits with Notified Bodies, Regulatory Authorities, and Customers to ensure a positive outcome.
- Maintain compliance with local and international regulatory compliance in line with relevant legislation.
- Maintain an awareness of new and proposed legislation that impacts the business and communicate/implement as required.
- Communicate effectively cross-functionally to ensure that quality and regulatory requirements are integrated into all aspects of product development and commercialization.
- Promote a culture of compliance to regulations, standards and procedures and risk management throughout the organisation.
Technical Skills
- Previous experience in either a Quality Engineering, Quality Assurance or Regulatory role with medical devices.
- Knowledge and experience in medical device Quality Management Systems and regulatory processes including ISO 13485, ISO 14971, ISO 27001, 21 CFR Part 11, 21 CFR Part 820, MDR 2017/745, IEC 62304.
- Proven track record in interactions with Notified Bodies and/or Regulatory Authorities, especially the FDA.
- Knowledge of UK, US and/or EU Data Protection Regulations (i.e. GDPR, DPA, HIPAA).
Additional Competencies
- Knowledge of the in-vitro diagnostic industry, including product development processes.
- Ability to navigate and stay updated on global regulatory landscapes, ensuring that the company remains compliant with evolving international regulations.
- Effective communication skills, both oral and written.
- Proficiency in reading, analysing and interpreting scientific and technical information.
- Medical Device start-up experience preferred.
- High degree of self-motivation and ability to work under pressure while maintaining accuracy.
- Strong team player with an analytical and problem-solving approach.
- Excellent project and time management abilities, including thorough and timely reporting.
- Good interpersonal skills.
- Impact-driven mindset, eager to make a positive difference for the company, product, users, and colleagues.
- Comfortable with both hands-on tasks and strategic thinking
- Creativity and adaptability in identifying and pursuing new avenues of inquiry.
About ZiO Health
ZiO Health is a medical technology & digital health company that has developed proprietary pocket-sized technology, bringing lab testing to the point of use.
We are changing the way we approach therapeutic drug monitoring and precision dosing. Our proprietary biosensor technology combined with AI-guided dosing allows us to provide immediate concentration results and personalized dose information to improve patient treatment outcomes and minimize toxicity.
How to Apply
If you're interested in applying for this position, please send us a short introduction and your CV to applicants@zio-health.com