Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Regulatory Affairs Specialist to join our team in Waterdown, ON.
Who we want
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement
• Dedicated achievers.
People who thrive in a fast-paced environment and will ensure a project is complete and meets regulations and expectations.
• Data translators. Highly effective communicators who can transform data findings into license applications, reports and varied communications vehicles
What you will do
As the Regulatory Affairs Specialist, you will proactively collaborate with internal teams/departments to promote a culture of inclusiveness and cooperation. You will be responsible to live and exemplify Stryker’s Values: Integrity, Accountability, People, and Performance.
- Author submissions and other regulatory documents to obtain approval to bring new or modified products to market. (Class I, II, III applications).
- Assess changes made to the device post launch to determine if the changes which are being made impact device license
- Utilize time management skills to effectively write, coordinate, and execute regulatory items.
- Work with Marketing to develop annual product submission plans.
- Stay abreast of regulatory procedures, evolving regulations and guidelines and changes in the regulatory climate.
- Assists with developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.
- Investigate regulatory history of similar products to assess approval implications.
- Attends to internal and external regulatory and licensing inquiries.
- Communicate with all functional groups to ensure awareness of regulatory and quality requirements.
- Ensures scheduled submission dates are met and reports to management and marketing staff on regulatory product status and submission progress.
- Respond to RA information requests.
- Assist in SOP development and review.
- Monitor and maintain departmental metrics.
- Completes other regulatory activities as assigned by manager.
- Abide by and support the policies set forth in the Stryker Code of Conduct.
- Understand that compliance with the Code of Conduct, as it may be amended by Stryker Corporation from time to time, is a condition of continued employment with Stryker.
- Conduct work in compliance with all laws, rules, and regulations and in accordance with Stryker’s high ethical standards.
- Report any violations of these policies and procedures to Stryker management or in the manner outlined in Stryker’s Ethics Hotline Policy.
What you need
- A minimum of a University Degree required.
- A minimum of a Post Graduate Diploma in Regulatory Affairs required.
- A minimum of 1 year of experience working in the Medical Device sector required.
- Previous experience in a Regulatory Affairs role preferred.
- Competent with Microsoft Office (Outlook, Excel, Word, etc.).
- Ability to understand and explain detailed regulatory compliance programs and/or issues.
- Ability to comply with constantly changing regulatory procedures and prioritize work effectively.
- Ability to analyze and resolve non-routine regulatory issues using independent judgment.
- Ability to communicate and network with regulatory personnel to obtain relevant information.
- Ability to negotiate internally and externally with regulatory agencies.
- Excellent analytical and writing skills.
- Complying with constantly changing regulatory procedures; reprioritizing work effectively.
- Identifying and correcting errors and inconsistencies (e.g. grammatical, contextual, etc.).
- Rapidly building product knowledge and understanding of highly technical and scientific regulatory activities.
Work From Home: Occasional
Travel Percentage: None
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