FDA · 10 hours ago

Biocompatibility Expert (Interdisciplinary Scientist/ Engineer)

Silver Spring, MD

Full-time

Remote

Senior Level

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GovernmentHealth Care

Growth Opportunities

No H1B

U.S. Citizen Only

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Responsibilities

Evaluates device biocompatibility and assesses biological risks, especially to avoid adverse reactions. The incumbent scientifically reviews and analyzes safety data to provide recommended guidelines and policy analyses for devices considering the regulatory implications of such reviews and analyses.

Writes and establishes policies and procedures that ensure the sufficiency and procedural adequacy of policy statements and policy initiatives. Interprets and applies existing policy, setting precedents that affect internal and industry program activities and the marketing of regulated products, specifically focusing on ensuring the consistency in biocompatibility policies, procedures, guidance and/or regulations.

Prepares replies to correspondence from the regulated community and other interested persons on issues that are industry-wide in scope or have broad health implications and that concern precedent setting interpretations of FDA policy related to biocompatibility.

Coordinates and leads Biocompatibility discussions with Medical Device Innovation Consortium (MDIC).

Leads development of chemistry proposals for discussions with external parties (e.g., professional societies and trade associations).

Ensures scientific standards ballot reviews are consistent with CDRH regulatory and scientific biocompatibility policy.

Leads development of review aids and training to facilitate review consistency (e.g., chemistry review templates and training) and adherence to CDRH regulatory and scientific biocompatibility policy.

Oversees development of programmatic changes in OPEQ biocompatibility programs and is responsible for coordinating with OPEQ Sub-office Leadership and SMEs to ensure appropriate implementation of programmatic changes.

Serves as a liaison for biocompatibility reviews on behalf of the OPEQ programs and activities with other Offices, as well as serves as a biocompatibility device evaluation liaison for cross-Office policy programs and those led by other Offices, other government agencies, standard development organizations (SDOs) or stakeholders (e.g., industry, consumer groups). Identifies and ensures the participation of subject matter experts, e.g., engineers, scientists, medical officers, etc. (expertise in working with medical devices) on a variety of OPEQ programs and policies, specifically focusing on biocompatibility policies, procedures, guidance and/or regulations.

Recommends long-range program plans, goals, objectives, and milestones, which serve as the basis for substantive changes in the organization and administration of programs affecting large numbers of people. Advises OPEQ senior management of issues impacting the Offices and initiates solutions, strategies, or policy development.

Researches and analyzes unstable or complex regulatory policy issues and based on conditions and factors, determines what information is required and collects data from many sources to determine whether additional training or corrective actions are necessary, specifically related to biocompatibility.

Serves as expert authority in OPEQ Immediate Office for biocompatibility review issues that may arise in Appeals or other similar scenarios requiring OPEQ IO input.

Serves as a principal advisor for the analysis, development and implementation of policies, procedures, guidance, and regulations specifically related to the oversight of biocompatibility review issues for device evaluation programs and activities. Provides advice on the interpretations of the laws, regulations, and policies applicable to the Center and FDA.

Qualification

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Biocompatibility expertisePolicy developmentRegulatory analysisBiological risk assessmentData analysisTraining developmentCollaboration with stakeholdersMedical device knowledge