Technical Advisor, Medical Product Development & Regulatory

Goldbelt, Inc.

Maryland

Hybrid

USD 100,000 - 140,000

Full time

3 days ago

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Benefits offered by this job

Medical, dental, and vision insurance

401(k) plan with company matching

Professional development opportunities

Job summary

Goldbelt Apex, part of the Healthcare Technology Transformation Group, is a data-focused company dedicated to process and quality in every aspect, seeking a Technical Advisor Support – WPAC.

The role provides scientific/medical/technical expertise supporting medical product development, with responsibilities across clinical research strategy, trial planning, regulatory review of IND/IDE packages, and technical documentation, advising product managers and leadership.

Qualifications

Medical/scientific product development experience.
Experience in clinical research.
Familiarity with FDA regulatory environment.
Ability to analyze complex technical information.
Strong technical writing and briefing skills.

Responsibilities

Provide scientific/medical/technical expertise supporting medical product development.
Support clinical research strategy, clinical trial planning and execution.
Review IND/IDE packages, regulatory submissions, clinical data, CMC and technical documentation.
Participate as technical SME on IPTs.
Provide written technical reviews, briefings and recommendations to product managers and leadership.

Skills

Medical product development

Clinical research

FDA regulatory environment

Technical writing

Briefing skills

Education

Medical degree or higher

Job description

Goldbelt Apex, part of the Healthcare Technology Transformation Group, is a data-focused company dedicated to process and quality in every aspect, seeking a Technical Advisor Support – WPAC.

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