Cloudely is the global leader for technology recruitment, supporting Salesforce, Robotic Process Automation (RPA), DevOps, Web and Mobile Programming skills and more. We have many opportunities throughout North America and India. By specializing solely in placing candidates in the high-tech market we have built relationships with most of the key employers and have an unrivalled understanding of where the best opportunities are.

Job Title: Regulatory Affairs Engineer

Location: Mounds View, MN

Duration: Long Term
 

Job Description:

• Assists the Regulatory Affairs Manager for ensuring compliance with the requirements set by the EU Medical Device Regulation and other regulatory bodies for Medical devices registration across different geographies
• Product Registration Support- APAC, LATAM, EMEA, Canada, China, Russia, Japan
• Prepare and review the documentation required for Change submission, Notification , Re-registration of Medical devices
• Provide guidance to the offshore team in the preparation of documents for change submission, notification, re-registration packages of Medical Devices for regulatory agencies submission.
• Understands existing technical files / design dossiers/Technical documentation summary by reviewing documentation available for compliance to CE mark of EU and prepare the Country specific STEDs.
• Performs a Regulatory watch to identify and respond to new or revised regulatory requirements as per the Input by Geo RAs
• Tracks the status of applications under regulatory review and provides updates to the Core Regulatory team.
• Maintains logs of communication and outcomes with regulators and other relevant internal or external stakeholders.
• Collects, organizes and maintains files on local, regional and global regulatory intelligence and other related information. 
• Researches requirements (local, national, international) and options for regulatory submissions, approval pathways and compliance activities.
• Maintains information systems (electronic and paper) for regulatory information and reports.
• Oversee and ensure maintenance of regulatory licenses renewals on timely manner
• Clearly conveys information to peers, supervisors and other stakeholders
• Supports the development of internal RA systems and procedures.
• Maintains SOPs related to RA activity and suggests update of the QMS
• Review of deliverables as Regulatory expert ( STED and Country specific documentation)

Must to have:
Product Registration Support- APAC, LATAM, EMEA, Canada, China, Russia, Japan
Health Canada, TGA, HAS, CFDA/NMPA, TFDA, PMDA, Anvisa ANMAT, MFDS, MOHW, SFDA, MOH
Regulatory Submissions / Global Regulatory Submissions/ International Submission
Medical Device Registration/ Re-registration/ Regulatory licenses renewals
Change submission, notifications
STED Preparation
Regulatory Approbation
EU MDD/MDR Tech documentation Summary
Notified Body
CE Technical File / EU Technical File / Design Dossier

Apply today!
Looking forward to receiving your resume through our website and going over the position with you. Clicking apply is the best way to apply, but you may also send your resume to: [email protected]. To learn more about Cloudely, Inc, please visit www.cloudely.com.

Cloudely, Inc is proud to be an Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.

Your Right to Work - In compliance with respective law prevailing in the country, all persons hired will be required to verify identity and eligibility to work in respective country and to complete the required employment eligibility verification document form upon hire.

We welcome the opportunity to speak to any candidates that are considering a new career or job either now or in the future.