RA & QA Manager

RA & QA Manager Position

Synchrony Medical, has developed LibAirty^TM - a next-generation, home use, airway clearance system for patients living with chronic lung diseases. Following two successful clinical studies, we are now growing and preparing for regulatory clearance and commercial launch. If you are interested in making a difference in the lives of millions of patients, come join us on this amazing journey!

Role and Responsibilities:

The RA & QA Manager will oversee all regulatory and quality aspects of the company. He/she will have the overall responsibility for directing and executing the company's regulatory strategy and quality assurance activities.

• Develop regulatory strategies and manage robust regulatory applications for international marketing approvals – US, EU, Amar
• Work closely and provide advice on regulatory requirements to R&D, Clinical, and Marketing representatives, throughout product lifecycle.
• Develop and execute comprehensive RA and QA plans to support product launch and commercial goals.
• Establish, implement, and manage Quality Management System (QMS) in compliance with FDA regulations, ISO standards, and other international regulatory requirements for class 2 medical devices.
• Work with manufacturing subcontractors to ensure quality and regulatory compliance throughout production processes.
• Manage activities such as audits and regulatory agency inspections.

Qualifications:

·      B.Sc./M.Sc. in life sciences, engineering or other relevant fields

·      8 years' experience in the medical device industry, at least 3 years management experience

·      In-depth knowledge of FDA requirements, ISO Standards, EU MDR and other international regulations, with a proven ability to prepare regulatory submissions, such as FDA 510(k) Premarket Notifications, EU MDR submissions and technical documentation

·      Experience with multi-disciplinary medical devices, containing both HW and SW components

·      Experience working with cross-functional teams on product development and manufacturing projects, including subcontractors and suppliers

·      Experience supporting audits by regulatory agencies, including GMP, ISO13485, and FDA

·      Experience working at a commercial stage medical device company - advantage

·      Ability to work independently in a fast-paced dynamic environment, with excellent organizational, planning and time management skills

Offices in Or Yehuda with flexibility for hybrid work, direct reporting to the CEO

Please send relevant CVs to: [email protected]