Sr. Staff Regulatory Affairs Specialist (Remote) (R450687)
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com
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. Stryker 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.
Stryker is looking to hire a Sr. Staff Regulatory Affairs Specialist to support new Stryker Surgical Products. This position can be either based in Portage MI, or be remote.
Who We Want:
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Curious learners. People who seek out cutting-edge research and information to expand and enhance their ability to be ready for what’s next.
Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.
What you will Do:
- Assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
- Participate in advocacy activities of a more advanced technical and/or tactical or strategic nature
- Evaluate the regulatory environment and contribute to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions
- Identify requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
- Assist in the development of regulatory strategy and updates strategy based upon regulatory changes
- Evaluate proposed products for regulatory classification and jurisdiction
- Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
- Provide regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
- Compare regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes
- Negotiate with regulatory authorities throughout the product lifecycle
- Identify the need for new regulatory procedures, SOPs, and participates in development and implementation
- Help train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
- Assist other departments in the development of SOPs to ensure regulatory compliance
- Provide regulatory input and technical guidance on global regulatory requirements to product development teams
- Advise stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
- Assess the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations
- Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions
- Provide knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships
- Identify, monitor, and submit applicable reports or notifications to regulatory authorities during the clinical research process
- Provide regulatory information and guidance for proposed product claims/labeling
- Ensure that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims
- Prepare and submit electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines
- Monitor the progress of the regulatory authority review process through appropriate communications with the agency
- Communicate and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools
- Work with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees
What you Need:
- BS in Engineering, Science, or related degree; or MS in Regulatory Science
- Minimum of 5 years’ experience in regulatory affairs or quality assurance
- Knowledge of US Class II devices
- Experience with new product development, clinical trials, 510k submissions, de novo submissions would be beneficial
- Ability to work well in a cross-functional team environment
- MS or RAC(s) preferred
Know someone at Stryker?
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