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Principal Regulatory Affairs Specialist

2 months ago

Portage, United States Stryker Group LLC Full time

We are currently seeking a

Principal Regulatory Affairs Speci

alist

for our Instruments division to be based hybrid in Portage, MI (relocation provided). 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 including panel/advisory committees

Possesses and applies comprehensive strategic and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.

What you need Bachelors degree required, preferably in Engineering, Science, or related

MS in Regulatory Science or Advanced degree preferred

9+ years experience in an FDA regulated industry required; preferably with medical devices.

7+ years of Medical Device Regulatory Affairs experience required.

Previous experience drafting regulatory submissions to FDA required

Experience interacting with regulatory agencies required

RAC(s) desired

Thorough understanding of the Quality System Regulations (21 CFR), Medical Device Directives (MDD) and MEDDEV guidance

Thorough understanding of other regulations related to Pre Market Clearance and Post Market Support

Previous experience with Class II/III medical devices required, experience with software or PPE desired.

Advanced PC skills with proficiency in Microsoft Office Suite, including Excel.

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