Regulatory & Sustaining Engineering Specialist
Mississauga, ON, Canada
The Regulatory Specialist is responsible for ensuring that all new product designs meet the necessary global regulatory standards including medical, laser and industrial. The individual in this role will review commercial specifications, identify regulatory requirements, participate in design activities and coordinate certification testing for advanced light delivery systems used in high power biomedical and industrial illumination applications. The scope of responsibilities covers the full product development life cycle, including product design and sustaining engineering support. The Regulatory Specialist is responsible for keeping up to date with all changes to relevant medical device, laser and industrial regulations to ensure Excelitas products comply to all new or changing requirements, including labeling.
Major Duties and Responsibilities
- Provide technical support for all R&D activities related to regulatory affairs including specific product design criteria, analyze product complaints and make design recommendation, maintenance of test agency certification records, CE Technical files/ declarations including additional records pertaining to regional environmental legislation
- Reviews product requirements to determine standards applicability for regulatory planning purposes including product safety and electromagnetic compatibility testing, as well as applicable restricted substance control requirements
- Creates and executes Regulatory Strategies and Plans for assigned products in the domestic and international markets, including assessments of the regulatory impact of changes to design, materials, labeling, software, and suppliers
- Provides costing and coordinate all product testing submittals for regulatory approval with appropriate agencies
- Performs selected on-site electrical safety tests.
- Supports internal and external quality audits
- Ensures product designs meet industrial and laboratory ESD, EMC, CE, UL, FDA (21 CFR 820) and low voltage/safety compliance regulations.
- Reviews and approves product labeling plans, labeling, and marketing communications
- Keeps up-to-date with the changes to relevant regulatory standards worldwide; supports sustaining engineering activities required to maintain regulatory compliance as new or revised versions of standards are released
- Creates EU Technical File and Declaration of Conformity documents (MDD, FDA, CE, RoHS, REACH, WEEE etc.) according to international guidelines.
- Author submissions and other regulatory documents to obtain approval to bring new or modified products to market
- Develops and maintain good relationships with internal team members as well as external vendors and contractors.
- Participate in research of regulatory issues and dissemination regulatory information to Production, QA and R&D departments and senior management as required
- Create the risk management procedures during the design and production of medical devices, includes identifying hazard, determining both the applicability of a hazard in creating harm and the severity of potential harms, assigning risk controls for unacceptable hazards and verifying and validating risk controls.
- Prepare or direct the preparation of laboratory samples, document as requested by regulatory agencies.
- Provides technical support for production and customer service department, conduct EOF components evaluation, testing and update design document and regulatory file as required.
- Develop or conduct employee regulatory training.
- Other duties as assigned.
- Bachelor's degree in Electrical Engineering or equivalent from a recognized institution.
- Minimum 10 years of regulatory experience in a product development environment or national test lab
- Regulatory affairs or compliance engineering experience in the Medical Device industry is preferred
- Experienced in electronic systems and subsystem design and test, systems analysis, software-driven operations and test schemes.
- Familiarity with IEC standards for Medical, laser and industrial Devices: IEC 60601, 60601-2-37, 60601-2-22, 62304, IEC 60825, IEC 62471, IEC 61326 other CE Mark requirements such as Technical Documentation Files and ISO 14971.
- Hands on experiences of EMC/EMI and safety design problems and solutions, as well as product approval procedures and requirements.
- Resourceful problem solver that is able to work around technical obstacles and will be adept at the implementation of practical solutions.
- Excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple and changing projects and priorities.
- Excellent verbal and written communication skills and the ability to interpret and summarize scientific results in a clear, concise, accurate manner.
- Self-starter with excellent attitude, initiative and passion for delivering the best.