Senior Regulatory Affairs Specialist (Hybrid)
Posted
Join Stryker's Medical Division supporting Emergency Care | Stryker as a Senior Regulatory Affairs Specialist based in Redmond, Washington (Hybrid). In this role, you will support the continued compliance, registration, and market availability of medical devices throughout their lifecycle by partnering with cross-functional teams on product changes and regulatory activities.
What you will do
- Support R&D, Marketing and Manufacturing teams with regulatory assessments of proposed changes or product transfers.
- 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.
- Prepare and submit electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines for required products.
- Provide regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization.
- Communicate and interact with regulatory authorities throughout the development and review process of a regulatory submission through appropriate communication tools.
- Evaluate proposed pre-clinical, clinical, and manufacturing changes for regulatory filing solutions and propose plans/strategies (if appropriate) for changes that do not require submissions.
- Identify, monitor, and submit applicable reports or notifications to regulatory authorities during the clinical research process.
- Maintain current product registrations and assist with processing registration changes when required.
What you need
- Bachelor’s degree required. Preferred to be in Engineering, Science, Regulatory Affairs, or a related technical field.
- Minimum of 2 years in a Regulatory Affairs role required.
- Experience in an FDA or highly regulated industry required.
Preferred
- Experience supporting Software as a Medical Device (SaMD) products or software-enabled technologies within a regulated industry.
- RAC certification or Advanced Degree (Masters in Regulatory Affairs).
- Previous experience with Class II/III medical devices.
- Experience authoring regulatory submissions for product approval.
- Experience interacting with regulatory agencies.
US15: $95,800 - $159,600 USD Annual
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