Regulatory Specialist

Department: Regulatory

Employment Type: Full Time

Location: US (Remote)

Reporting To: Sr. RA Manager, Extremities

Description

Key Responsibilities

• 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.

• 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.

• 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.

• 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.

• 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

• Bachelor's degree from an accredited institution required. Relevant experience may be considered in lieu of education.

• 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.

• 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.