Job Summary
The RA Sr. Specialist is responsible for ensuring products imported by Zimmer Biomet Canada are in compliance with all applicable Canadian law / regulations. The incumbent is responsible for developing and maintaining productive relationships with key stakeholders including Canadian and global business partners and Health Canada. This role will manage pre-market / post-market regulatory projects from beginning to end while ensuring alignment between regulatory requirements, business objectives and corporate values. This position requires an advanced understanding of medical devices and their use as well as an understanding of the regulatory submissions process.
Principal Duties and Responsibilities
Author and publish Medical Device License applications (new and amended) for Class II, III, IV medical devices in accordance with Health Canada (HC) regulations and guidance documents. Collaborate with Legal Manufacturers to respond to HC requests as needed.
• Stay abreast of changes to the CMDR and develop new local strategies for continued compliance
• Lead the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products • Provides country specific regulatory input to development project teams and recommend local regulatory strategy for new products and line extensions
• Evaluate risk of proposed regulatory strategies; develop creative solutions in anticipation of roadblocks
• Review and evaluate proposed labeling for compliance with CMDR
• Review and evaluate promotion and advertising material for compliance with Canadian regulations
• Life cycle maintenance including but not limited to review of proposed product changes for impact on regulatory status of the product and determine the appropriate HC reporting requirements; support MDL renewals
• Communicate with regulatory and governmental agencies as well as industry association groups on behalf of Zimmer Biomet
• Assist with establishment license renewals and maintenance activities
• Applies HC regulations to business practices and provides regulatory input, advice and guidance to manufacturing and local stakeholders including marketing and operations
• Assist with quality systems maintenance and improvement activities including SOPs, cross-functional training, and internal audits
• Assist with Health Canada inspections and corporate / third party audits
Expected Areas of Competence
• Knowledge of the Food and Drugs Act, Medical Device & CTO regulations; FDA/EU is an asset
• Excellent team collaboration and teamwork skills
• Strong attention to detail; project/submission management skills, ability to multi-task and balance competing priorities
• Knowledge of overall business environment, the orthopaedic industry, and the marketplace
• Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products as needed, based on functional area
• Ability to build relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels
• Strong writing, communication, and interpersonal skills
• Ability to identify risk in Regulatory strategies
• Strong problem solving skills
• Effective negotiating skills
• Knowledge of e-submission management tools is an asset
Education/Experience Requirements
• Bachelor's degree in science / engineering (or non-US equivalent) required; advanced science degree preferred
• Regulatory Affairs Certification (RAC) or Post grad studies in RAQA preferred
• A minimum of 2 years of experience in orthopaedic or medical device industry preferred
• A minimum of 5 years of experience in Regulatory Affairs, Engineering, Quality, or related field required
• A combination of education and experience may be considered
Travel Requirements
Up to 15%
Additional Information
EOE M/W/Vet/Disability
