Regulatory Affairs Medical Devices jobs

Position Overview

Our rapidly expanding team is seeking a Senior Regulatory Affairs Associate to support regulatory sciences and clinical operations teams located in Guelph, ON. The Senior Regulatory Affairs Associate will provide leadership and support for various regulatory projects. The main responsibilities of the successful candidate will include the oversight and preparation of various regulatory submissions to support clinical trials and market access while ensuring compliance with applicable global policies, procedures, and regulatory guidelines.

Primary Responsibilities:

· Preparation and oversight of regulatory submissions and related documentation to primarily Health Canada, including Natural Health Product (NHP) Clinical Trial Applications (CTAs), Master Files, and Product License Applications (PLA), according to current Agency requirements.

· Interacts with internal and external groups to provide regulatory affairs consultative support for projects.

· Initiates and manages regulatory affairs projects to ensure content complies with emerging or new requirements.

· Identifies gaps in submission dossier to meet local requirements.

· Leads and provides guidance in the development and implementation of regulatory strategies.

· Liaises with functional areas to coordinate and compile information required for regulatory documentation.

· Interprets and makes decisions relating to regulatory guidelines and policies.

· Advises management on changes to regulations, standards and legal stipulations, and ensures SOPs and Work Instructions are updated to reflect such changes.

· Liaises with Health Canada and other regulatory agencies, as needed.

· Keeps abreast of domestic and global regulatory trends, laws. and movements.

· Maintains positive and cooperative communications and collaboration with all internal and external stakeholders.

Core Competencies:

· Knowledge and experience in the Natural Health Products Regulations, associated regulatory principles, processes, and industry standards.

· Excellent communication skills with an ability to translate regulatory and scientific complexities into actionable guidance.

· Strong understanding of safety and efficacy evaluations.

· Excellent organizational time management and communication skills.

· Excellent interpersonal and public relation skills with ability to work well in a team.

· Solid problem-solving skills with an ability to identify solutions to problems under critical deadline constraints.

· Strong technical writing skills, and ability to review and critique regulatory documents.

· Ability to work independently with efficiency and accuracy and high attention to detail.

· Computer literacy with MS Office and Adobe Acrobat.

Qualifications:

· Advanced degree in a scientific discipline such as Pharmacology, Toxicology, Nutrition Science, Biochemistry, Regulatory Science, or related field.

· 8+ years of increasing responsibility in Regulatory Affairs/Regulatory Sciences for natural health products, supplements, OTCs, or similar regulated sectors.

· Proven experience preparing and submitting Class I–III NHP applications.

Pay: $60,000.00-$90,000.00 per year

Work Location: In person