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Regulatory Engineer

Absolute Information Technologies Inc.

This is a Contract position in Minneapolis, MN posted June 9, 2020.

Title Regulatory Engineer Location Minneapolis, MN, Santa Rosa, CA Duration 6 Months Interview Phone and Skype Job Description In regards to COVID-19
– the client will interview remotely through phone or video conference and onboardstart you working remotely.

Primary Activities 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.

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 dossiersTechnical 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 pathwaysand 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 Secondary Activities Supports the development of internal RA systems and procedures.

Maintains SOPs related to RA activity and suggests update of the QMS Skills Experience Required skills Technical Bachelorrsquos degree in a science discipline with Regulatory knowledge (European Medical device directive and Medical device Regulation, Familiarity with standard related to Quality Management Systems (ISO 13485, 21CFR Part 820) Knowledge in geography specific regulatory requirements for medical devices (APAC, LATAM, EMEA, Canada, China, Russia.) Regulatory experience and Project Management experience, registration and submissions experience from medical device industry.

Very good written and oral communication in English.

Ease for readingcreatingmodifying documents.

Able to work with minimal supervision.

Self-motivated team player.

Kind Regards,