Position: Medical Devices Regulatory Affairs Consultant
Job Summary:
The Medical Device Regulatory Affairs Consultant is the go-to person for all matters associated with this market. The incumbent will be responsible for authoring submissions, SOPs, procedures, and all other technical and non-technical documents and communications associated with medical devices.
Job Responsibilities:
• Authors submissions and other regulatory documents to obtain approval to bring new or modified products to market. (Class I, II, III, IV applications)
• Manages communications with regulatory agencies and external partners.
• Manages the preparation of technical documentation as well as creation and update of procedures for the MDSAP
• Prepares all the SOP associated with the MDSAP and ISO13485 registration process and audit
• Participates in MDSAP audit as a regulatory SME as required
• Assists in responding to requests for additional information from regulatory authorities
• Conducts post-market surveillance activities on new product
• Maintains and updates device listings, device licenses, and establishment registrations
• Monitors markets for regulatory changes to applicable regulations and requirements and communicates changes across the organization
• Provides regular reports to management on the status of regulatory submissions, licenses/clearances, and registrations
• Supports quality and compliance activities as needed (e.g. change control, audits)
• Monitors budgeted hours and ensures projects are completed in an appropriate time frame
Job Qualifications:
• Bachelors of Science (Master in science preferred), or a related discipline
• Experience working for a consulting firm preferred
• Certificate in Regulatory Affairs would be an asset
• 2+ years working in a similar role
• In-depth knowledge of Canadian, US, and international regulations for medical device is a definite advantage
• Excellent analytical abilities
• Understanding of risk management
• Effective organizational skills and strong attention to detail in order to successfully oversee regulatory initiatives, multitask and handle fluctuating workloads
• Well-developed interpersonal and communication skills (oral, written, computer-proficient) with the ability to present ideas, solutions, and strategies in a clear and concise manner
• Adaptable to changing environment, client, and project needs
• Self-motivated, possess initiative, and able to work productively with minimal supervision
• Excellent project management and follow-up skills, deadline-oriented with a strong ability to prioritize tasks
We value the following qualities in all of our team members:
• High-quality standards, responsibility, and engagement
• Ability to interact with a range of personalities and many levels of the organization
• Demonstrated self-motivation and the ability to take initiative
• Project management and strong prioritization skills
• Attention to and ability to execute details
• Adaptable to changing environment, client, and project needs
Job Type: Full-time
Location: Opportunity to work remotely or in Toronto, ON office.
Benefits Include:
• Disability insurance
• Dental Care
• Extended health care
• Life insurance
• Vision care
• Wellness program
• Work remotely: