Regulatory Affairs Specialist

Regulatory Strategy and Product Lifecycle Management

• Develop and support global regulatory strategies for new products, product modifications, market expansions, and lifecycle management activities.
• Assess the regulatory impact of product, manufacturing, supplier, labeling, and quality system changes, and define required actions.
• Provide regulatory input during product development, including applicable requirements, testing needs, submission pathways, and anticipated approval or clearance timelines.
• Monitor evolving regulations, standards, and regulatory expectations and communicate potential business or product impacts to stakeholders.

Regulatory Submissions and Registrations

• Prepare, compile, review, submit, and maintain regulatory submissions and supporting documentation for product approvals, clearances, registrations, renewals, and amendments.
• Author or support U.S. FDA 510(k) submissions and Q-Submissions; EU MDR/IVDR technical documentation; Health Canada license applications and amendments; and international registrations and product notifications.
• Respond to questions, requests for additional information, and deficiencies issued by regulatory authorities and notified bodies.
• Coordinate submission content, testing requirements, deliverables, and timelines with internal stakeholders and external partners.

Technical Documentation and Regulatory Records

• Create, review, update, and maintain technical documentation, design dossiers, registration records, licenses, certificates, and regulatory databases.
• Ensure regulatory documentation remains accurate, current, traceable, and compliant throughout the product lifecycle.
• Maintain visibility to global registrations and market authorizations, including applicable renewal and expiration requirements.
• Support documentation readiness for regulatory inspections, notified body audits, and internal audits.

Regulatory Compliance and Change Management

• Participate in change control activities and evaluate proposed changes for regulatory impact, reporting requirements, and implementation constraints.
• Review and approve product labeling and other regulated documentation, as assigned.
• Develop and maintain regulatory procedures, work instructions, protocols, and best practices.
• Partner with Quality and cross-functional teams to address compliance issues and complete regulatory corrective and preventive actions arising from audit or inspection findings.

Regulatory Authority and External Partner Interaction

• Interface with regulatory authorities, notified bodies, international representatives, distributors, and external regulatory partners regarding submissions, registrations, and compliance activities.
• Support regulatory inspections, external audits, technical reviews, and follow-up activities.
• Collaborate with in-country representatives and regulatory partners to obtain and maintain product registrations and licenses.

Cross-Functional Collaboration

• Partner with Research and Development, Quality Assurance, Clinical Affairs, Manufacturing, Supply Chain, Marketing, and other functions to integrate regulatory requirements into business and product activities.
• Communicate regulatory requirements, risks, dependencies, and timelines clearly to stakeholders.
• Lead or participate in regulatory meetings, project teams, continuous improvement initiatives, and other assigned projects.

Experience

• Three to five years of Regulatory Affairs experience preferred, ideally within the medical device, in vitro diagnostic, biotechnology, or life sciences industry.
• Experience preparing or supporting U.S., EU MDR/IVDR, Health Canada, and international regulatory submissions.
• Experience maintaining technical documentation, product registrations, and regulatory compliance throughout the product lifecycle.
• Experience with regulatory change assessments, labeling reviews, authority questions, audits, inspections, or corrective and preventive actions is preferred.

Preferred Qualificationsnice to have

• Regulatory Affairs Certification (RAC) preferred.
• Experience interfacing directly with the U.S. FDA, notified bodies, Health Canada, or other regulatory authorities.
• Working knowledge of FDA regulations and guidance, EU MDR/IVDR, Health Canada Medical Device Regulations, global registration processes, and ISO 13485 quality management systems.

Core Competencies

• Strong technical writing, document review, and records management skills.
• Sound regulatory judgment, analytical thinking, and problem-solving ability.
• Effective project management, prioritization, and organizational skills.
• Ability to manage multiple priorities and work independently in a deadline-driven environment.
• Clear communication and effective collaboration with cross-functional and global stakeholders.

• Medical coverage

• 401(k)

• Parental leave

• Fertility benefits

• Paid time off

• Paid holidays

Travel

• Remote-based with occasional travel to CSI locations or Regulatory meetings, conferences, and audits.