Work Flexibility: Hybrid
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at www.stryker.com.
We are currently seeking a Senior Regulatory Affairs Specialist to join our Global RAQA Division to be based in Waterdown, Canada.
As the Senior Regulatory Affairs Specialist, you are responsible for assisting in Stryker Canada’s Regulatory compliance activities for the commercialization of healthcare products. This individual must serve as a contributing member of the Regulatory Affairs team while championing Stryker’s Mission and Values.
What you will do
- Develops and executes local regulatory strategies for all license applications and launch activities.
- Provides regulatory input and technical guidance on local regulatory requirements to product development teams. Identifies potential obstacles for market access distribution.
- Authors and submits medical device applications (Class II, III, and IV) to Health Canada. Collaborates with manufacturers to strategically address application deficiencies in accordance with the timeline dictated by Health Canada.
- Assesses post-market product changes to determine if the changes impact the device license. Develop and execute plan with cross-functional partners (Operations, Marketing, etc.) to manage any business impact.
- Plans and organizes project assignments and maintains project schedules in accordance with the business plan. Communicates progress to plan, risks, and needs to appropriate business functions.
- Provides input on regulatory-related issues associated with compliance and achieving the business plan.
- Develops solutions to a variety of complex problems of diverse scope and complexity. Applies a full understanding of area of specialization to resolve a wide range of issues in creative ways.
- Review marketing material to ensure adherence to applicable regulatory requirements.
- Establishes relationships with local medical device industry groups (ex. Medtech Canada) and works with industry peers to lobby in matters of regulatory issues and to influence local policies.
- May lead projects within the function or department and/or represents a specialized field in larger project teams.
- Establishes and cultivates a wide range of collaborative business relationships to facilitate completion of assignments.
- Provide supporting information for license and certification renewals (ex. MDEL, DEL, NHP Site License) as required.
- Stay abreast of regulatory procedures, evolving regulations and guidelines and changes in the regulatory climate.
- Monitor and maintain departmental metrics.
- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Completes other regulatory activities as assigned by manager
What you need
- University Degree required
- Post-Graduate Diploma in Regulatory Affairs completed or in process an asset
- At least three years of hands-on experience in a regulatory submission preparation.
Preferred
- A Post Graduate Diploma in Regulatory Affairs or Quality Assurance preferred.
- Working knowledge of medical device regulations.
- Strong computer skills (Excel, Word, Power Point, Share point).
- Highly organized and able to prioritize tasks.
- Project management and report writing preferred.
Travel Percentage: None