Senior Regulatory Affairs Specialist
BioTalent
Core Responsibilities
- Manage and resolve regulatory information requests by delivering accurate, complete, and audit-ready data packages aligned with global regulatory expectations.
- Conduct structured regulatory risk assessments, perform impact analyses on design and manufacturing changes, and communicate mitigation strategies to cross-functional engineering, quality, and clinical teams.
- Support end-to-end regulatory submissions through detailed reviews of product labeling, clinical and human-factors study protocols, verification/validation documentation, and quality system records.
- Lead development of global regulatory pathways by coordinating with international regulatory counterparts to execute product registrations, renewals, and maintenance activities across multiple regions.
- Ensure alignment with internal quality system requirements by authoring and updating controlled procedures, work instructions, and regulatory-impact documentation.
- Uphold organizational standards for compliance, data integrity, engineering collaboration, and technical accountability.
- Contribute technical expertise to additional regulatory or quality initiatives as assigned.
- Bachelor's degree in a scientific, engineering, or regulated-industry discipline.
- 5+ years of experience in regulatory affairs or quality engineering within the medical device sector, including
- Working knowledge of U.S. regulatory and quality frameworks (e.g., medical device regulations, quality system requirements, and applicable FDA/industry standards spanning clinical practice, laboratory practice, and design controls).
- Ability to support limited domestic or international travel (approx. 15%).
- Demonstrated capability to deliver regulatory leadership throughout the product lifecycle, including regulatory strategy development, design change assessment, submission planning, and documentation review.
- Strong technical writing proficiency with experience authoring structured regulatory submissions for diverse global markets.
- Expertise using productivity and project-management software to manage timelines, technical documentation, and cross-functional deliverables.
- Proven communication and collaboration skills, enabling effective interface with engineering, quality, clinical, and manufacturing functions.
- Strong organizational capability with the discipline to manage multiple technical workstreams concurrently.
- Experience supporting global regulatory operations and coordinating with geographically distributed teams.
- Regulatory Affairs Certification (RAC) is preferred.
Vacancy posted 5 days ago
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