Position: Medical Devices Regulatory Affairs Consultant
Location: 603-7 St Thomas St., Toronto, ON
Responsibilities:
• Author submissions and other regulatory documents to obtain approval to bring new or modified products to market. (Class I, II, III, IV applications).
• Management of communications with regulatory agencies and external partners.
• Manage preparation of technical documentation as well as creation and update of procedures for the MDSAP
• Prepare all the SOP associated with the MDSAP and ISO13485 registration process and audit
• Participate in MDSAP audit as a regulatory SME as required
• Assist in responding to requests for additional information from regulatory authorities
• Conduct post-market surveillance activities on new product
• Maintain and update device listings, device licenses, and establishment registrations
• Monitoring markets for regulatory changes to applicable regulations and requirements and communicate changes across the organization
• Providing regular reports to management on the status of regulatory submissions, licenses/clearances and registrations.
• Supporting quality and compliance activities as needed (e.g. change control, audits)
Qualifications:
• Bachelors of Science (Master in science preferred), or related discipline
• Experience working for a consulting firm preferred
• Certificate in Regulatory Affairs would be an asset
• 5 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 attention to detail in order to successfully oversee regulatory initiatives
• Well-developed communication skills (oral, written, computer-proficient) with the ability to present ideas, solutions, and strategies in a clear and concise manner
• Personality characterized by high-quality standards, responsibility, and engagement
• Ability to interact with a range of personalities and many levels of external and internal clients
• Excellent organizational, interpersonal, and communication skills
• Adaptable to changing environment, client, and project needs
• Monitoring budgeted hours and ensuing projects are completed in an appropriate time frame
• Self-motivated, possess initiative, and able to work productively with minimal supervision.
• You maintain strong attention to detail with the ability to multitask and handle fluctuating workloads simultaneously.
• Excellent project management and follow-up skills and are deadline-oriented with a strong ability to prioritize tasks.
In addition, we value the following qualities in our team members:
• Personality characterized by 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