Regulatory Affairs Specialist

This is a fully remote position, open to applicants in Connecticut.

📋 Description

• Develop and support global regulatory strategies for new products, product modifications, market expansions, and lifecycle management activities.

• Evaluate the regulatory implications of changes in product, manufacturing, suppliers, labeling, and quality systems.

• Provide regulatory guidance during product development, including requirements, testing necessities, submission pathways, and timelines for approval or clearance.

• Stay updated on changing regulations, standards, and regulatory expectations, and communicate their impact on business or products.

• Prepare, compile, review, submit, and maintain regulatory submissions and accompanying documentation.

• Author or assist with U.S. FDA 510(k) submissions and Q-Submissions, EU MDR/IVDR technical documentation, Health Canada licensing applications and amendments, as well as international registrations and product notifications.

• Address inquiries, requests for information, and deficiencies posed by regulatory authorities and notified bodies.

• Coordinate submission content, testing requirements, deliverables, and timelines with both internal stakeholders and external partners.

• Create, review, update, and maintain technical documentation, design dossiers, registration records, licenses, certificates, and regulatory databases.

• Ensure regulatory documentation remains accurate, up-to-date, traceable, and compliant throughout the product lifecycle.

• Maintain awareness of global registrations and market authorizations, including renewal and expiration obligations.

• Assist in preparing documentation for regulatory inspections, notified body audits, and internal audits.

• Engage in change control activities and assess proposed changes for their regulatory impact, reporting requirements, and implementation challenges.

• Review and approve product labeling and other regulated documentation.

• Develop and maintain regulatory procedures, work instructions, protocols, and best practices.

• Collaborate with Quality and cross-functional teams to resolve compliance issues and finalize regulatory corrective and preventive actions.

• Interface with regulatory authorities, notified bodies, international representatives, distributors, and external regulatory partners.

• Support regulatory inspections, external audits, technical reviews, and follow-up actions.

• Work with in-country representatives and regulatory partners to secure and uphold product registrations and licenses.

• Collaborate with Research and Development, Quality Assurance, Clinical Affairs, Manufacturing, Supply Chain, Marketing, and other departments to integrate regulatory requirements.

• Communicate regulatory requirements, risks, dependencies, and timelines to stakeholders.

• Lead or participate in regulatory meetings, project teams, continuous improvement initiatives, and assigned projects.

⛳️ Requirements

• Regulatory Affairs Certification (RAC) is preferred.

• Experience in direct interaction with the U.S. FDA, notified bodies, Health Canada, or other regulatory authorities.

• Proficient understanding of FDA regulations and guidance, EU MDR/IVDR, Health Canada Medical Device Regulations, global registration processes, and ISO 13485 quality management systems.

• Strong skills in technical writing, document review, and records management.

• Sound regulatory judgment, analytical thinking, and problem-solving abilities.

• Effective project management, prioritization, and organizational capabilities.

• Ability to manage multiple priorities and work independently in a deadline-oriented environment.

• Clear communication skills and effective collaboration with cross-functional and global stakeholders.

• Three to five years of experience in Regulatory Affairs is preferred, ideally within the medical device, in vitro diagnostic, biotechnology, or life sciences sectors.

• Experience in preparing or supporting U.S., EU MDR/IVDR, Health Canada, and international regulatory submissions.

• Familiarity with maintaining technical documentation, product registrations, and regulatory compliance throughout the product lifecycle.

• Experience with regulatory change assessments, labeling reviews, authority inquiries, audits, inspections, or corrective and preventive actions is preferred.

• A Bachelor's degree in Regulatory Affairs, Engineering, Biological Sciences, Chemistry, Life Sciences, or a related scientific field.

• An equivalent combination of education, training, and relevant experience may be considered.

🏝️ Benefits

• Medical coverage.

• 401(k).

• Parental leave.

• Fertility benefits.

• Paid time off for vacation, personal, sick days, and holidays.

• Multiple additional perks and benefits.

• Occasional travel to CSI locations or for regulatory meetings, conferences, and audits.