Principal Regulatory Affairs Specialist (Remote)

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 …