Acro Service Corp · 13 hours ago
Regulatory Affairs Specialist
San Clemente, CA
Full-time
Hybrid
Entry, Mid Level
$30/hr - $35/hrAcro Service Corp is seeking a Regulatory Affairs Associate II to support medical device regulatory activities, focusing on EU MDR compliance. This role is crucial for ensuring regulatory readiness and successful submissions across global markets.
ConsultingHuman ResourcesInformation TechnologyStaffing Agency
Hiring Manager
Vivek Kumar
Responsibilities
Support preparation and maintenance of EU MDR Technical Documentation
Assist with regulatory submissions and remediation projects
Collaborate with cross-functional teams to ensure compliance
Interface with regulatory authorities as needed
Qualification
Required
Bachelor's degree required
Medical Device Regulatory Affairs
EU MDR remediation activities
Regulation (EU) 2017/745
Technical Files / Technical Documentation
GSPR (General Safety & Performance Requirements)
510(k) submissions
Interaction with FDA and/or Notified Bodies
ISO 13485 Quality Management Systems
EU MDR compliance initiatives
Preferred
Pharmacy, Biology, Chemistry, Pharmacology, Engineering, or a related field
Company
Acro Service Corp
With singular global reach and agility, Acro Service Corporation offers you a unique integrated approach to staffing and consulting solutions.
Founded in 1982
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Chris Ehrhart, CCWP
VP - Global Supplier Partnerships
Staci Dodson Beurer SPHR, SHRM-SCP, CSP
Chief People Officer (VP, HR)
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