Medical Devices Regulatory Affairs Consultant

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

Applying:
To be considered for future opportunities, please email your cover letter, resume/CV, and any related supporting documentation to hr@dicentra.com 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.

Inclusion:
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.

Work remotely:
• Temporarily due to COVID-19
• Sanitizing, disinfecting, or cleaning procedures in place