Senior Manager – Compliance Training
Boeing
Senior Regulatory Affairs Specialist
Stryker
full-time
Posted on:
Location Type: Hybrid
Location: Redmond • Washington • 🇺🇸 United States
Visit company websiteSalary
💰 $88,800 - $142,300 per year
Job Level
Senior
About the role
- 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
Requirements
- Bachelor’s degree in an Engineering, Science, or equivalent field
- Minimum of 3 years of experience in an FDA or highly regulated industry required
- Minimum of 2 years in a Regulatory Affairs role required
- Preferred RAC certification or Advanced Degree (Masters in Regulatory Affairs)
- Previous experience with US Class II/III medical devices
- Experience authoring regulatory submissions for product approval
- Experience interacting with regulatory agencies
Benefits
- Eligible for bonuses
- Generally eligible for short-term and long-term financial incentives
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory submissionsregulatory strategy developmentregulatory classificationcompliance activitiesregulatory filing solutionsproduct registration maintenanceclinical research reportingmarket access distributionregulatory approval pathwaysproduct lifecycle management
Soft skills
communicationinterpersonal skillsproblem-solvingstrategic planningcollaboration
Certifications
RAC certificationBachelor's degreeMaster's degree in Regulatory Affairs
