Regulatory Affairs Specialist Associate

1 week ago


Mississauga, Canada Zimmer Biomet Full time

**Requisition Number**: AMER27090

**Employment Type**: Full-time

**Location**: Mississauga

**Job Summary**: Zimmer Biomet is a global medical technology leader. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.
The RA Associate 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 post-market regulatory projects from beginning to end while ensuring alignment between regulatory requirements, business objectives and corporate values

**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 required - Experience in Regulatory Affairs, Engineering, Quality, or related field considered an asset - A combination of education and experience may be considered

**Travel Requirements**: Up to 15%

**Additional Information**: At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. This is why we offer you a competitive rewards package that includes medical, dental, vision, life and disability insurance, wellness incentives, employee assistance programs as well as paid time off for vacation and holidays.
EOE/M/W/Vet/Disability



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