Regulatory Affairs Specialist

Job not on LinkedIn

🔥 7 minutes ago

🦌 Connecticut – Remote

🦌 Connecticut – Remote

💵 $80.4k - $107.2k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 4%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Just posted.
• Jobs at this company usually fill in 39 days.

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CooperCompanies

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1978

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

💰 Post-IPO Equity on 2021-12

Healthcare • Consulting • Food & Beverage

CooperCompanies is a global, consumer-centric medical device company that supports how people want to live at every stage of life. The company is dedicated to improving lives by listening closely to healthcare providers and patients to fulfill the needs of today while focusing on the opportunities of tomorrow through innovation and strategic investment. Their prominent divisions, CooperVision and CooperSurgical, are committed to addressing issues such as myopia in children and supporting families struggling with infertility. CooperCompanies actively engages in sustainable practices and seeks to elevate standards of care with a strong focus on social and environmental impact.

📋 Description

• 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

• 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

• 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

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