At NeuronicWorks, we provide complete product development and manufacturing services. We offer end-to-end product design and prototyping, from concept development and detailed design to prototyping, certification, and manufacturing. Our goal is to deliver high-quality designs through visionary, innovative, and practical solutions for our customers.
The Regulatory Compliance and Quality Manager is responsible for ensuring that our designs and products as well as our organization comply with applicable regulatory requirements, standards, and market-specific regulations. This role also ensures the effectiveness of our Quality Management System and that products are consistently designed and manufactured in accordance with quality and safety requirements.
Responsibilities:
- Identify applicable regulations for each design and target market (e.g. Canada, US, EU, etc.).
- Ensure compliance with applicable medical device regulations (where applicable), customer regulatory requirements, and product directives.
- Monitor changes in regulations and standards and maintain regulatory compliance plans for products and projects.
- Prepare regulatory submissions and technical documentation where required.
- Interface with regulatory authorities and notified bodies when required.
- Coordinate regulatory inspections and internal audits.
- Verify suppliers meet applicable regulatory obligations and support supplier regulatory assessments.
- Ensure manufacturing processes meet applicable regulatory requirements.
- Maintain regulatory procedures and compliance documentation.
- Ensure regulatory-specific training is maintained.
- Manage adverse event reporting when applicable.
- Ensure risk management complies with applicable regulatory requirements.
- Assess regulatory impact of engineering changes.
- Own and maintain the Quality Management System (QMS).
- Ensure compliance with ISO 9001 and ISO 13485 QMS requirements.
- Review and revise NWI internal ISO 9001 and ISO 13485 Standard Operating Procedures (SOPs) and related forms as needed to reflect current practices.
- Review of outside client and in-house SMT Assembly PCBA documents (Gerber, Pick N Place, ODB++ and BOM files) and provide guidance to SMTA staff.
- Experience with FDA 510(k) submissions is preferred.
Personal Requirements:
- 10+ years of experience with North American product compliance requirements, including UL, CSA, FCC, and ISED Canada regulations for commercial and consumer electronic products.
- Strong knowledge of applicable European regulatory requirements, including the Low Voltage Directive (LVD), EMC Directive, Radio Equipment Directive (RED), RoHS, REACH, WEEE, and associated harmonized standards.
- Experience with North American and European product certification, telecom regulatory requirements (FCC, ISED), and industry certification programs, including PTCRB and GCF.
- Strong knowledge of IPC standards for printed circuit boards and electronic assemblies, including IPC-A-600 and IPC-A-610.
- Excellent verbal and written English communication skills, with the ability to communicate effectively at all organizational levels and with external auditors, regulatory bodies, customers, and suppliers.
- Ability to work independently while fostering collaboration across engineering, manufacturing, supply chain, and management teams.
- Customer-focused mindset with a commitment to continuous improvement and operational excellence.
- Ability to lead internal and external audits and effectively respond to audit findings.
- Capable of training NWI staff on the following ISO 9001 and ISO 13485 standards.
- Ability to maintain confidentiality and handle sensitive business and regulatory information.
- Familiarity with electronic components, Printed Circuit Boards (PCBs) and Printed Circuit Board Assemblies (PCBAs) are preferred.
Education:
- B.Sc. Electrical Engineering or equivalent.
- An active P.Eng. license or being in the process of obtaining licensure is preferred.
You will work in an environment that will give you an opportunity to excel and advance in your career. Our office is conveniently located in North York, easily accessible by public transit.
Benefits:
- Vision care
- Dental care
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- Casual dress
- Company events
Ability to commute/relocate:
- North York, ON M3B 2T5: reliably commute or plan to relocate before starting work (required)
Work Location: In person
Job Types: Full-time, Permanent
While we sincerely thank all applicants, only those selected for an interview will be contacted.
No Agencies, please.
Pay: $90,000.00-$120,000.00 per year
Benefits:
- Casual dress
- Dental care
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- Vision care
Work Location: In person
