Regulatory Affairs Specialist

CooperCompanies

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

Posted 11/10/2026full-timeRemote • Connecticut • United StatesMid-LevelSenior💰 $80,434 - $107,245 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing and supporting regulatory strategies, managing regulatory submissions, and ensuring compliance throughout the product lifecycle. Proficient in technical writing, project management, and collaboration with cross-functional teams to address regulatory requirements and challenges.

Highest-signal resume keywords

Regulatory Affairs Certification (RAC)U.S. FDA Submission ExperienceEU MDR/IVDR KnowledgeTechnical Writing SkillsRegulatory Compliance Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentRegulatory Submission PreparationTechnical Documentation MaintenanceRegulatory Change AssessmentQuality Management Systems (ISO 13485)

Soft Skills

Analytical ThinkingProblem-Solving AbilityEffective CommunicationProject ManagementOrganizational Skills

Certifications & Qualifications

Regulatory Affairs Certification (RAC)

Industry Keywords

Medical Device RegulationsIn Vitro DiagnosticBiotechnologyLife SciencesGlobal Registration Processes

About the role

Key responsibilities & impact

Develop and support global regulatory strategies for new products, product modifications, market expansions, and lifecycle management activities
Assess regulatory impact of product, manufacturing, supplier, labeling, and quality system changes
Provide regulatory input during product development, including requirements, testing needs, submission pathways, and approval or clearance timelines
Monitor evolving regulations, standards, and regulatory expectations and communicate business or product impacts
Prepare, compile, review, submit, and maintain regulatory submissions and supporting documentation
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 information, and deficiencies from regulatory authorities and notified bodies
Coordinate submission content, testing requirements, deliverables, and timelines with 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, current, traceable, and compliant throughout the product lifecycle
Maintain visibility to global registrations and market authorizations, including renewal and expiration requirements
Support documentation readiness for regulatory inspections, notified body audits, and internal audits
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
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
Interface with regulatory authorities, notified bodies, international representatives, distributors, and external regulatory partners
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
Partner with Research and Development, Quality Assurance, Clinical Affairs, Manufacturing, Supply Chain, Marketing, and other functions 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

What you’ll need

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
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
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 preferred
Bachelor's degree in Regulatory Affairs, Engineering, Biological Sciences, Chemistry, Life Sciences, or a related scientific discipline
An equivalent combination of education, training, and relevant experience may be considered

Benefits

Comp & perks

Medical coverage
401(k)
Parental leave
Fertility benefits
Paid time off for vacation, personal, sick and holidays
Multiple other perks and benefits
Occasional travel to CSI locations or regulatory meetings, conferences, and audits