Principal Regulatory Affairs Specialist (Remote)
Michigan, Portage 1941 Stryker Way
We are currently seeking a Principal Regulatory Affairs Specialist for our Instruments division to be based remotely anywhere in the US.
Who we want
Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
Goal-oriented orchestrators. People who can effectively coordinate and focus the work of skilled employees toward an important goal, prioritizing to the right activities that lead to success.
Business-oriented evaluators. People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management and leadership teams.
What you will do
As the Principal Regulatory Affairs Specialist, you will support new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based upon regulatory changes. You will be viewed as the global regulatory team resource ensuring regulatory compliance by completing thorough assessments and submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies.
Assesses links between global, societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy
Participates in advocacy activities of a more advanced strategic nature
Develops and updates global, regional and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategies
Provides guidance to integrate regulatory considerations into global product entry and exit strategy
Identifies regulatory pathways for initial product designs and provides input to internal stakeholders
Analyzes the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends changes or refinements based on initial regulatory outcomes
Assesses all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, etc.) and develops solutions to address anticipated obstacles
Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations
Provides in-depth understanding and ability to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needs (e.g. orphan, conditional approval, breakthrough therapy)
Negotiates with regulatory authorities on complex issues throughout the product lifecycle
Establishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution
Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures
Develops and manages programs that train stakeholders on current and new regulatory requirements to …
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Remote
Benefits/PerksBenefits Bonus eligible Bonus eligible + benefits Remote work Salary plus bonus eligible + benefits Travel Percentage Work flexibility
Tasks- Development
- Develop regulatory strategy
- Ensure regulatory compliance
- Implementation
- Support product development
- Train stakeholders
Budgeting Compensation Compliance Data analysis Engineering Excel Forecasting GCP Leadership M Market Access Medical Devices Microsoft Office Microsoft Office Suite Negotiation Office Suite Organization Product Development Regulatory Affairs Regulatory Compliance Regulatory requirements Regulatory strategy Reimbursement Reporting Sales Sales Strategy Stakeholder management Strategic planning Technical Training Development
Experience5 years
EducationAdvanced degree Business Engineering MS
TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9