About the role
Primary Purpose
Develops regulatory positions, drafts complex filings, and leads cross-functional coordination for compliance initiatives. Strengthens strategic outcomes by ensuring submissions meet regulatory standards and advance organizational interests.
Duties and Responsibilities
Required Education
Develops regulatory positions, drafts complex filings, and leads cross-functional coordination for compliance initiatives. Strengthens strategic outcomes by ensuring submissions meet regulatory standards and advance organizational interests.
Duties and Responsibilities
- Develops positions and drafts complex filings (new registrations, significant variations, rate cases with customer impact models); structures arguments and evidence for approval.
- Coordinates cross‑functional evidence packages (quality systems, testing, safety, customer impact) and aligns timelines to regulator milestones.
- Advises on compliance for growth initiatives (new product lines, acquisitions, market entries); outlines regulatory pathways, risks, and mitigations.
- Leads root‑cause reviews after audit or inspection findings; designs corrective and preventive actions that address system causes.
- Represents the organization in technical committees or industry forums; explains compliance rationale and proposed policy outcomes.
- Crafts well‑supported responses to deficiency letters or data requests; negotiates realistic timelines and commitments.
- Leads small improvement projects (submission quality improvements, labeling claim libraries, change‑control enhancements) with measurable outcomes.
- Mentors junior staff on drafting techniques, regulator engagement, and evidence building.
- Performs other duties as assigned.
Required Education
- Typically requires a 4 year degree in a relevant field, or equivalent combination of relevant education and experience.
- Typically requires 5 years of related experience.
- Ability to assess regulatory and compliance risks associated with business or operational changes.
- Ability to balance regulatory expectations with operational objectives.
- Ability to contribute expert regulatory or compliance input to cross-functional initiatives.
- Knowledge of regulator and auditor expectations.
- Knowledge of regulatory and compliance frameworks across multiple lifecycle stages or processes.
- Skill in drafting, reviewing, and refining complex regulatory or compliance documentation.
- Skill in interpreting regulations, guidance, and internal policies with limited direction.
About this listing
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