Principal Regulatory Affairs Specialist - $130

Minneapolis  ‐ Onsite
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Keywords

Description

ESSENTIAL DUTIES AND RESPONSIBILITIES
* Participation in the development of regulatory strategies and prepare regulatory submissions
* US submissions include IDEs, 510(k)s and PMAs
* EU submissions include filing and amending Technical Files
* Other markets as required
* Creation, review and approval of labeling
* Approved labeling, including IFUs, packaging, etc.
* Promotional labeling, including advertisements, promotional pieces and professional education materials
* Reporting
* Medical Device Reports (MDRs)
* EU vigilance Reporting
* Represent Regulatory Affairs on various cross-functional teams:
* Corrections and Removals

§ Regulatory Affairs is a standing member of the Recall Team
§ Regulatory Affairs functions as the Recall Coordinator
· Determines if a correction or removal is necessary and if notification of any regulatory agency is required
· Reviews all news releases or other official company statements

* Design Control
§ Contribute to the development of the project plan and other deliverables
§ Represent Regulatory Affairs in the development of Product Plans, Specifications, Risk Management and other required documents
§ Participate in Design Reviews when appropriate

* Document Control
§ Regulatory Affairs is a standing member of the Change Control Board (CCB)
§ Create and revise procedures as needed.
§ Review and approve change orders and evaluate for submission requirements.

* Corrective and Preventative Action (CAPA)
§ Regulatory Affairs is a standing member of the Corrective and Preventive Action Board (CAB)

* Complaint System
§ Evaluate complaints for potential reporting obligation

* Internal Audits
§ Participate as an auditor, independently if appropriately trained

* Other duties as assigned

QUALIFICATIONS

A Bachelors degree in engineering or life science required. Higher degrees can substitute for years of experience. Must have ten years experience in a regulated medical device company in regulatory, clinical affairs or quality assurance with a minimum of five years in regulatory affairs, preferably with PMA products. Must have strong writing, editing and analytical skills and have experience in developing complex submissions with minimal supervision. Knowledge of US and international regulatory requirements including clinical regulations, design control, medical device submissions requirements, labeling and promotion regulations, quality control, auditing principles, and adverse event reports. Must work well independently or within a cross-functional team environment. Certification as ISO Auditor, or ISO Lead Auditor desirable.

To find out more about Real please visit www.realstaffing.com
Start date
10/2013
From
Real Staffing
Published at
27.09.2013
Project ID:
604228
Contract type
Permanent
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