Senior Regulatory Affairs Specialist

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 work streams concurrently.
• Experience supporting global regulatory operations and coordinating with geographically distributed teams.
• Regulatory Affairs Certification (RAC) is preferred.