Position Title
Regulatory Affairs Project Manager
SBU
Corporate
Department
Regulatory Affairs
Relocation Covered
Potential
Educational Requirements
Bachelor's degree
Experience Requirements
Responsible for corporate-wide projects within the Regulatory Affairs Department, at the direction of Regulatory Affairs Management.
Qualification Requirements
Bachelor of Arts or Bachelor of Science degree in a business, engineering, medical or science discipline Have a comprehensive understanding of worldwide regulatory requirements, and use this knowledge to conduct activity on a project basis, based upon the needs of regulatory submissions, compliance and quality systems.
Preferred Qualifications
A minimum of 5-7 years medical device industry experience. A minimum of 5-7 years regulatory affairs/compliance experience. Extensive knowledge of US, European and international regulations and regulatory requirements. Extensive knowledge of medical device industry standards and guidance documents. Knowledge and understanding of QSR and ISO quality system documentation requirements. Project management experience.
Responsibilities
Responsible for identifying areas within the company that require Regulatory Affairs Project Management to improve the company's compliance to regulatory requirements. Manage and support a variety of regulatory projects, including, but is not limited to, the following areas: European regulatory requirements, e.g. design dossier and technical file compliance, vigilance reporting, application and use of European harmonized standards to Arrow products, etc. United States regulatory requirements, e.g. premarket notification (510(k)) compliance, MDR reporting, quality system compliance, application and use of FDA guidance documents, etc. Asia/Pacific regulatory requirements, e.g. submissions and registrations, adverse event reporting, interaction with Arrow's contract Regulatory Agencies and Distributors. Canadian regulatory requirements, e.g. license applications, adverse event reporting. Development and communication of regulatory strategies for worldwide markets. Recalls, field actions, product holds, internal and external audits of Arrow's quality systems. Facility registrations and product listings, ISO and EC Certificate maintenance, foreign registration maintenance. Interface and negotiation with regulatory agencies for new products and compliance-related issues. Train company personnel (as necessary) on worldwide regulations and regulatory requirements. Support Product Development Teams (as necessary) for new product introductions. Provide other departmental support as requested by immediate supervisor. Adhere to and ensure the compliance of Arrow's Code of Conduct, all Company policies, rules, procedures, and housekeeping standards.
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