Senior Regulatory Affairs Specialist

About the job

As a member of our Regulatory team, you will proactively drive launch of new products in markets/geographies through Regulatory expertise and support marketing and product development initiatives by providing strategic global regulatory guidance.

Provide accurate, relevant, and timely information internally and externally, to maintain product regulatory compliance, and to support approval of regulatory submissions for global product markets.

Responsibilities Include:

Strategy

• 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 have 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 right claims to achieve high yield with 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 is maintained and internal parties are appropriately informed.
• Maintain current body of knowledge on regulations and standards that may impact regulatory approvals for products currently being marketed
• Complete annual renewals and international registration updates as necessary
• Evaluate impact of changes on regulatory compliance.
• Evaluate temporary deviations and nonconformance reports for Adverse Effects and regulatory compliance
• Support regulatory and customer audits.

Relationship Management

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

Post Market Surveillance Activities

• Act as Post Market Surveillance (PMS) Agent for specific product lines
• Review Customer Feedback within established timeframes for reportability
• Approve Complaint Closure Reports
• Report trends from product feedback to support continuous improvement, vigilance activities and management reviews
• Actively participate in annual Post Market Surveillance meetings
• Perform appropriate Vigilance Activities (reports, advisory notices, etc.)

Compliance

• Comply with Company policies, operating procedures, and processes

Health and Safety

• Ensure compliance with relevant health and safety legislation, including the Workplace Safety and Insurance Act, the Occupational Health and Safety Act, etc.

QUALIFICATIONS

• Degree in health or biological sciences, or a related field
• Certificate in Regulatory Affairs or equivalent work experience
• Minimum of 5 years of regulatory experience in a medical device environment
• Developed strategies and documentation to support submissions and approval of medical device applications globally
• Knowledge and understanding of regulations governing medical devices in Canada, US and Europe is an asset
• Knowledge of the requirements of an ISO 13485 quality program
• Excellent oral and written communication skills, including technical writing.
• Computer literate with:
  • Advanced experience in a Windows environment
  • Advanced experience in MS Word
  • Advanced experience in MS Excel
• Basic knowledge of Enterprise Resource Planning (ERP) software, e.g. Great Plains Dynamics is and asset
• Experience using database software to manage data and records is an asset.
• Strong organizational and general administrative skills
• Demonstrated attention to detail.
• Strong interpersonal skills with ability to communicate effectively with internal personnel and external parties, e.g., customers

At an applicant’s request, TMI will make accommodation to its recruitment process to meet the needs of applicants with disabilities.

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