Regulatory Lead

To be considered for this position please complete the following application Regulatory Lead

Responsibilities: 

-Lead, develop and implement regulatory strategy to meet company goals and objectives

-Draft, review, edit, and approve regulatory documents

-Draft, review, edit, and approve documents for Company eQMS

-Provide regulatory oversight and guidance to project teams on compliance matters, labeling, health authority 

 requirements, and clinical study design issues, logistics, and operational recommendations for product development

-Accountable for the development and submission of regulatory documents (e.g., 510k, PMA, post market surveillance, 

 responses to regulatory queries, , etc.)

-Facilitate problem-solving and drive decision-making around complex regulatory, preclinical, clinical and development 

 issues by program teams

-Partner with various other functional groups to plan and execute an effective regulatory strategy in alignment with the 

 overall product and clinical development plan

-Lead and facilitate meetings with regulatory agencies and prepare internal teams for these interactions

-Ongoing management of the regulatory strategy including regulatory research to stay updated on pertinent regulatory 

 changes as they affect product development or deployment

-Assist with the identification of hazards and risks and provide input on mitigation strategies

-Identify potential regulatory risks to the strategic/operational plans, and propose options to mitigate risks

-Provide senior management with strategic advice on potential product lines based on current regulatory landscape

Must have experience in one of these areas (must be able to select adequate resources (e.g. consultants) to assist with knowledge gaps when needed):

In Vitro Diagnostic Medical Devices

FDA (preferred)

EU

Canada

Veterinary Biologics (USDA)

Scientific Equipment/General Consumer electronics

EU (CE-marking)

US (Requirements for commercialization (e.g. FCC). 

 

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