Regulatory Affairs Specialist

CooperCompanies•Trumbull, CT

2h•$80,434 - $107,245•Remote

About The Position

The Regulatory Affairs Specialist II supports global regulatory activities throughout the product lifecycle for medical devices, in vitro diagnostics (IVDs), and life science products. The role develops and executes regulatory strategies, prepares and maintains regulatory submissions and technical documentation, manages global product registrations, and supports ongoing compliance with applicable requirements. The Specialist II serves as a regulatory partner to cross-functional teams, providing guidance for product development, design and manufacturing changes, labeling, market expansion, and compliance initiatives. The role also supports interactions with regulatory authorities, notified bodies, international representatives, and external partners. The position is remote-based with occasional travel to CSI locations or regulatory meetings, conferences, and audits.

Requirements

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.
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.
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.

Nice To Haves

Regulatory Affairs Certification (RAC).
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.
Experience with regulatory change assessments, labeling reviews, authority questions, audits, inspections, or corrective and preventive actions.

Responsibilities

Develop and support global regulatory strategies for new products, product modifications, market expansions, and lifecycle management activities.
Assess regulatory impacts 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.
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.
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.
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.
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.
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.
Travel occasionally to CSI locations or regulatory meetings, conferences, and audits.