Regulatory Affairs Specialist Chrono-log Corp. Havertown, PA Job Details Full-time $65,000 - $100,000 a year 17 hours ago Benefits Health savings account Health insurance Dental insurance 401(k) Paid time off Vision insurance 401(k) matching Life insurance Retirement plan Qualifications Teamwork Technical documentation Engineering Bachelor's degree Biomedical regulatory compliance Quality audits Manufacturing Full Job Description Founded in 1956 as a digital time display company, Chrono-log pivoted into medical devices in the 1960's and have been a leader in our field ever since. Today, we bring together engineering, design, and a personal touch to create meaningful technologies benefiting both clinical diagnostics and scientific research worldwide. We are seeking an experienced Sr. Regulatory Affairs Specialist to support global regulatory compliance and drive submissions. In this role, you'll lead FDA 510(k) filings, maintain international registrations, support audits, develop SOPs, and partner closely with technical teams to ensure products meet regulatory and quality standards. If you excel at interpreting regulations, managing complex documentation, and guiding teams through compliance requirements, this is an opportunity to make a meaningful impact in an innovative environment. If you enjoy navigating complexity, influencing outcomes, and helping teams bring impactful technologies to market, this role is for you. What You'll do Assist in regulatory strategy across medical device development projects Prepare global submissions for, USA, Canada and Europe Assist in providing documentation for submittal to international regulatory bodies. Respond to requests from foreign government and /or distributors as needed Ensure compliance with

ISO 13485, EU

IVDR, Health Canada SOR 98/282 and 21 CFR 820 Develop technical documentation and quality records Facilitate risk management including FMEA and Hazard Analysis Assist with regulatory and quality requirements Improve Chrono-log's Quality Management system and regulatory capability What You Bring Degree in Engineering, Biomedical Engineering, Industrial Design, Science, or similar 5+ years in medical device development or manufacturing 4+ years in Regulatory Affairs within medtech Experience preparing regulatory submissions and supporting approvals Strong understanding of

ISO 13485, EU IVDR, 21 CFR 820

Experience with FMEA, Hazard Analysis, and risk management RAC, FRA, or equivalent credential (desirable) Collaborative, motivated and organized Benefits Employer Funded Retirement Plan Health Insurance Vision Insurance Dental Insurance Health Savings Account (HSA)

Paid Time Off Life Insurance Pay:

$65,000.00 - $100,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Health savings account Life insurance Paid time off Retirement plan Vision insurance

Education:

Bachelor's (Preferred)

Experience:

Regulatory Affairs:

4 years (Required)

License/Certification:

RAC, FRA, or equivalent credential (Preferred)

Work Location:

In person