Quality and Regulatory Affairs Specialist
Sonic Incytes is seeking a Quality and Regulatory Affairs specialist who will work under the guidance of our Sr. Quality and Regulatory consultants and be responsible for the implementation, maintenance, and operation of the quality management system, for obtaining and maintaining global regulatory registrations, and for supporting internal and external audits for our medical device.
- Create and maintain Quality System Procedures (QSPs) for compliance with FDA 21 CFR Part 820, Health Canada, MDSAP, EU MDR and ISO 13485 requirements
- Guide Sonic Incytes’ staff in the creation of all required quality records/documentation including (but not limited to) DMR, DHF, DHR, Change Requests, Non-Conformance Reports etc.
- Responsible for document control and records management
- Support internal and external audits with the potential of serving as the Management Representative for the organization and assist with annual Management Review Meetings
- Lead product post-market surveillance activities and submit reports to external agencies as needed
- Monitor the non-conformance, corrective action and preventive action system
- Lead product risk management reviews and related activities
- Provide QMS training as required to personnel at Sonic Incytes
This position will report to the Director of Product. This role is based in our Vancouver, British Columbia office.
You are an early/mid career professional with experience establishing and operating quality systems for medical devices. You are super excited about the opportunity to establish a quality system from scratch and lead a team of product development professionals in bringing a novel medical device to market. We don’t expect you to know everything – your work will be guided by our senior quality system and regulatory consultants. You are passionate, dedicated, a self starter and able to work independently as you provide guidance to our product development team in all things quality system related. You are excited about working closely with a diverse team consisting of engineers, clinicians and business personnel and you excel in dynamic and collaborative environments.
Our Ideal Candidate
- 3-5 years hands on experience in quality and regulatory affairs (in the healthcare or life sciences industry will be an asset, medical device industry preferred)
- Working knowledge of FDA QSR, ISO 13485, MDSAP, EU MDR, FDA and Health Canada regulatory requirements
- Experience in creating and maintaining Quality System Procedures for compliance with FDA 21 CFR Part 820, Health Canada, MDSAP, EU MDR and ISO 13485 requirements
- Experience in internal auditing and leading and/or supporting external audits
- Experience in software and/or manufacturing environments, including knowledge of relevant standards (e.g., ISO 14971, IEC 62304, IEC 60601-1, IEC 60601-1-2, IEC 62366, etc.)
- Experience in technical writing (e.g. SOPs, product user manuals, report writing)
- Self-motivated with strong written and verbal communication skills, excellent interpersonal skills, and collaborative;
About Sonic Incytes
Sonic Incytes is developing a breakthrough, handheld ultrasound solution, Velacur™, for assessing and managing chronic liver disease – an emerging global health crisis, affecting one in four persons worldwide. Fatty liver disease is the fastest growing and largest segment of chronic liver disease, driven largely by the increasing prevalence of diabetes and obesity. The continued growth in patients and the emergence of digital and drug therapies creates an urgent need for a cost-effective, quick, and accurate diagnostic solution to assess and manage the progression and treatment of this disease. For more information about the company, please visit www.sonicincytes.com.