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AI Summary
The Regulatory Operations Specialist manages international product registrations, renewals, and lifecycle documentation to ensure global market access. They also conduct regulatory assessments to authorize product releases and maintain compliance with international regulatory requirements.
Regulatory Specialist
Department: Regulatory
Employment Type: Full Time
Location: US (Remote)
Reporting To: Sr. RA Manager, Extremities
Description
The Regulatory Operations Specialist is responsible for supporting international regulatory activities for medical devices across all global markets excluding Australia, Canada, Japan, and New Zealand. This role coordinates regulatory submissions, registrations, renewals, product release approvals, certificate management, and regulatory documentation requests to support global market access and business continuity.
Working closely with Regulatory Affairs, Quality, Supply Chain, Manufacturing, Commercial teams, and external regulatory partners, the Regulatory Operations Specialist ensures regulatory records, approvals, and submissions are maintained in compliance with applicable country-specific requirements.
Key Responsibilities
Regulatory Registrations and Lifecycle Management
- Prepare, compile, submit, and maintain regulatory registrations for international markets.
- Coordinate new product registrations, registration amendments, responses to regulatory authority inquiries, and registration renewals.
- Track registration status, renewal timelines, submission milestones, and regulatory commitments.
- Maintain registration records and databases to ensure accurate and timely regulatory compliance.
- Partner with internal stakeholders and external representatives to support successful market authorizations.
Product Release Approval (PRA) Management
- Conduct regulatory assessments to verify that all applicable market authorization, registration, licensing, and regulatory approval requirements have been satisfied before product is released for distribution in international markets.
- Review and evaluate registration status, approval validity, expiration dates, and market-specific regulatory requirements to determine product release eligibility.
- Authorize product release for commercial distribution in markets where all regulatory requirements have been met.
- Block or restrict product release when required registrations, licenses, approvals, or renewals are not in place or have expired.
- Collaborate with Regulatory Affairs, Supply Chain, Quality, Manufacturing, and Commercial teams to ensure regulatory compliance and uninterrupted market access.
- Monitor registration expiration dates, renewals, suspensions, and regulatory changes that may impact product release status.
- Maintain PRA documentation, records, and audit-ready evidence supporting product release and product hold decisions.
- Communicate product release decisions, regulatory risks, and registration status updates to relevant stakeholders in a timely manner.
Certificate and Documentation Management
- Process Certificate to Foreign Government (CFG) requests and supporting documentation requirements.
- Prepare and maintain Letters of Authorization (LOAs), Powers of Attorney (POAs), notarizations, legalizations, and apostille documentation.
- Manage regulatory certificates, including issuance, renewal tracking, distribution, and archival.
- Fulfill Regulatory Affairs documentation requests from internal stakeholders, distributors, and regulatory agencies.
- Ensure accurate document control and maintenance of regulatory records.
Regulatory Intelligence
- Monitor regulatory changes and updates within assigned international markets.
- Track emerging registration requirements, changes in regulatory processes, and compliance obligations.
- Communicate relevant regulatory updates to Regulatory Affairs and cross-functional stakeholders.
- Support implementation of regulatory process changes resulting from evolving regulatory requirements.
Regulatory Operations Support
- Monitor shared Regulatory Affairs inboxes and ensure timely response to regulatory requests and inquiries.
- Maintain regulatory tracking tools, databases, and submission logs.
- Support preparation of metrics, status reports, and regulatory activity tracking.
- Assist with continuous improvement initiatives to enhance regulatory operational efficiency and compliance.
- Support audits and inspections by providing regulatory documentation and records as required.
Skills Knowledge and Expertise
Education:
- Bachelor's degree from an accredited institution required. Relevant experience may be considered in lieu of education.
Experience:
- 3 to 5+ years of experience in medical device Regulatory Affairs, Regulatory Operations, or related regulated industry experience.
- Experience supporting international product registrations and regulatory submissions.
- Familiarity with medical device registration and maintenance requirements in international markets.
- Experience coordinating regulatory documentation and certificate management activities.
Functional/Technical Knowledge, Skills and Abilities Required:
- Knowledge of global medical device regulatory requirements and registration processes.
- Strong organizational and project coordination skills.
- Excellent attention to detail and documentation management capabilities.
- Strong written and verbal communication skills.
- Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
- Proficiency with Microsoft Office applications and regulatory document management systems.
Ability to work effectively with cross-functional teams and external regulatory partners.
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