Regulatory Affairs Specialist II

ARK Diagnostics, Inc. is seeking a highly skilled and detail-oriented Regulatory Affairs Specialist II to support US/EU/UK/ROW device listing/registration and ensure compliance with local and international regulatory requirements.

Requirements

• BS/MS in the Life Sciences, Biomedical Engineering, Regulatory Affairs, or equivalent discipline
• At least 2 years of relevant experience in domestic and international Regulatory Affairs Medical Device industry
• Sound knowledge of U.S. and European/International Regulatory requirements and Quality System Standards
• Experience with international product registrations, license renewals and/or permits
• Regulatory Affairs Certification (RAC), desirable

Benefits

• 401(k) and 401(k) matching
• Health, dental, and vision insurance
• Health Savings Account (HSA) and Flexible Spending Account (FSA)
• Life insurance
• Paid time off
• Employee Assistance Program (EAP)
• Tuition reimbursement
• Referral program