Senior Regulatory Affairs Specialist

Job Description

Overview

Senior Regulatory Affairs Specialist position with Kelly FSP for a Medical Device client in Markham, ON. This is a hybrid role (3 days a week in office).

Senior Regulatory Affairs Specialist

As a member of the Regulatory team, you will proactively drive the launch of new products in markets/geographies through regulatory expertise and support marketing and product development initiatives by providing strategic global regulatory guidance. You will provide accurate, relevant, and timely information internally and externally to maintain product regulatory compliance and support approval of regulatory submissions for global product markets.

Responsibilities

• Develop international strategies for regulatory approval of medical devices through regulatory/product competitive research and insights.
• Drive clarity on risks and methods to overcome them to deliver market-centric products in the shortest possible time.

Regulatory Submissions

• Lead regulatory submissions, including filing and/or creation of Dossiers, 510(k) Submissions, Applications, Change Notifications, and other country-specific product registrations.
• Prepare robust regulatory applications with the right claims to achieve high yield with a strategy to accelerate product launch success.

Regulatory Approval Maintenance

• Maintain ongoing surveillance, analysis, and dissemination of all relevant international medical device regulations to ensure regulatory compliance and informed internal parties.
• Maintain current knowledge of regulations and standards impacting regulatory approvals for products currently marketed.
• Complete annual renewals and international registration updates as necessary.

Evaluate

• Evaluate the impact of changes on regulatory compliance.
• Evaluate temporary deviations and nonconformance reports for adverse effects and regulatory compliance.

Audits

• Support regulatory and customer audits.

Relationship Management

• Interface with regulatory agencies as needed and build strong relationships.
• Provide the voice of international regulatory affairs on project planning and cross-functional project teams, driving clarity for market access with claims strategy.
• Maintain positive and cooperative communications with all levels of employees, customers, contractors, and vendors.
• Support regulatory, customer, and internal audits.

Post Market Surveillance (PMS) Activities

• Act as Post Market Surveillance (PMS) Agent for specific product lines.
• Review customer feedback within established timeframes for reportability.
• Approve Complaint Closure Reports and report trends to support continuous improvement and vigilance activities.
• Participate in annual Post Market Surveillance meetings and perform appropriate vigilance activities (reports, advisory notices, etc.).

Compliance and Health & Safety

• Comply with company policies, operating procedures, and processes.
• Ensure compliance with relevant health and safety legislation (e.g., Workplace Safety and Insurance Act, Occupational Health and Safety Act).

Qualifications

• Bachelor’s Degree in health or biological sciences, or a related field.
• Certificate in Regulatory Affairs or equivalent work experience.
• 10 years of regulatory experience in a medical device environment within Health Canada.
• Familiarity with current Canadian regulations.
• Experience developing strategies and documentation to support submissions/approval of medical device applications globally, specifically in Canada.
• Knowledge of regulations governing medical devices in Canada, US, and Europe is an asset.
• Knowledge of ISO 13485 quality program requirements.
• Excellent verbal and written communication skills, including technical writing.
• Computer literacy with advanced experience in Windows, MS Word, and MS Excel.
• Experience using database software to manage data and records is an asset.
• Strong organizational and administrative skills with attention to detail.
• Strong interpersonal skills and ability to communicate effectively with internal and external stakeholders.

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