Principal Regulatory Affairs Specialist (Remote)

Work Flexibility: 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 ensure organization-wide compliance

• Provides strategic input and technical guidance on global regulatory requirements to product development terms

• Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions

• Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions

• Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans

• Monitors implementation of regulatory strategies relative to product and clinical safety issues identified during clinical phases

• Provides knowledge and critical analysis of preapproval inspections, GCP inspections and clinical investigator relationships

• Provides regulatory guidance on strategy for proposed product claims/labeling

• Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims

• Manages electronic (eCTD) and paper registration development

• Ensures policies and procedures are in place for appropriate internal review and approval of regulatory submissions

• Leads key negotiations and interactions with regulatory authorities during all stages of the development and review process

• Prepares cross-functional teams for interactions with regulatory authorities in