Medical Devices Regulatory Affairs Consultant

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:

To be considered for future opportunities, please email your cover letter, resume/CV, and any related supporting documentation to with “Medical Devices Regulatory Affairs Consultant” in the subject line.

As part of the hiring process, in addition to interviewing, successful candidates may be required to complete a skills assessment and a reference/background check. If you are sent a skills assessment, please complete it for consideration for the advertised position.

We thank all applicants for their interest, however, only those selected for an interview will be contacted.

dicentra is firmly committed to creating a welcoming, accessible, respectful, and inclusive environment at our company in all divisions. We support the safety of employees and clients of diverse backgrounds and experiences. We also strive to meet individualized accessibility to ensure full inclusion for everyone. If you are selected to proceed through the hiring process and need a reasonable accommodation, please inform the company representative that contacts you.

About dicentra:

dicentra is a contract research organization and professional consulting firm that specializes in addressing all matters related to safety, quality and compliance for all product categories in the life sciences and food industries. We evaluate, implement, and provide all the necessary support for our client’s products and operations, allowing them to gain market access while building confidence in their brand.

We achieve this through our four business divisions:
Life Sciences Consulting
Food Safety & Quality Consulting
Global Certifications
Clinical Trials

Our team of experts works collaboratively to protect and improve our client’s businesses. We strive to promote a dynamic environment and encourage our team to continuously develop and enhance their skills and expertise, resulting in innovative solutions for our clients.