Description
Coordinate and document regulatory activities, including audits, inspections, license renewals, and product registrations; compile, prepare, and submit materials to regulatory authorities to obtain and sustain approvals.
- • Liaise with regulatory agencies on pre-submission strategies, pathways, test plans, and submission follow-up.
- • Prepare, coordinate, and review domestic and international regulatory submissions.
- • Interpret new and revised regulations and embed requirements in corporate policies and procedures.
- • Provide technical review of data, reports, and labeling to ensure scientific rigor, accuracy, and clarity.
- • Review promotional materials, labeling, packaging, and specifications for regulatory compliance.
- • Advise project teams on premarket requirements, export rules, labeling, and study compliance.
- • Compile and maintain regulatory documentation repositories and tracking systems.
- • Coordinate cross-functional efforts to prepare regulatory dossiers and responses.
- • Determine required submission types and internal documentation for product or labeling changes.
- • Develop and deliver regulatory training to employees and project teams.
- • Monitor, interpret, and communicate emerging regulations, standards, and guidance.
- • Obtain and distribute updates on domestic and international laws, guidelines, and standards.
- • Participate in and support internal and external audits and inspections.
- • Prepare, or coordinate preparation of, additional information and responses during agency reviews.
- • Create and maintain technical files and product registration documentation to secure and sustain approvals.
- • Recommend and implement updates to procedures in response to regulatory changes.
- • Prepare responses to customer regulatory inquiries, surveys, and data requests.
- • Review clinical or post-market study protocols to ensure data support for submissions.
- • Write and update SOPs, work instructions, and regulatory policies.
- • Coordinate recall, field action, or market withdrawal activities as needed.
- • Develop, monitor, and report regulatory and quality performance metrics.
- • Coordinate the collection and submission of samples or supporting materials requested by regulators.
- • Review adverse events and ensure timely reporting per regulatory requirements.
- • Identify and apply relevant guidance documents, international standards, and consensus standards.
- • Provide pre-, during-, and post-inspection support and follow-up for regulatory inspections.
- • Evaluate and recommend disposition of product complaints from a regulatory perspective.
- • Track and ensure timely renewals of registrations, licenses, permits, and listings.
- • Maintain submission calendars, trackers, and timelines to meet regulatory milestones.
- • Support change control and risk assessments from a regulatory standpoint.
- • Coordinate electronic publishing (e.g., eCTD) with internal teams or vendors for on-time submissions.
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Tasks & skills:
O*NET occupational data (work activities, skills, knowledge).
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This site includes information from O*NET by the U.S. Department of Labor, Employment and Training Administration (USDOL/ETA), used under the CC BY 4.0 license. Career Clutch has modified some of this information for student readability. USDOL/ETA has not approved, endorsed, or tested these modifications. O*NET® is a trademark of USDOL/ETA.
Last reviewed: Jan 2026
