Instrumentation Laboratory Company

Senior Principal Regulatory Affairs Specialist - Transfusion

Instrumentation Laboratory Company • $110K — $130K *
Norcross, GA 30093In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in science, engineering or related field required.
  • RAPS certification and membership preferred.
  • Minimum of eight (8) years of regulatory affairs experience in the medical device industry required.
  • Thorough knowledge of product development and design control processes.
  • Sophisticated knowledge of FDA and EU medical device regulations, Good Clinical Practices, ISO standards, and risk management regulations.

Responsibilities

  • Coordinate preparation and submission of product applications (510(k), BLA, Medical Device Licenses).
  • Prepare and maintain Technical Files and Documentation.
  • Review and approve quality system documents for compliance.
  • Evaluate significant changes for regulatory impact and reporting requirements.
  • Maintain regulatory product files for domestic and international registrations.
  • Coordinate field action and vigilance activities for products.
  • Evaluate complaint data to determine reporting needs and compliance.

Benefits

  • Collaborative work environment with cross-functional teams.
  • Opportunity to influence regulatory processes and compliance standards.
  • Engagement in high-stakes product safety and quality initiatives.
Full Job Description
Overview

Job Summary

As a Senior Principal Regulatory Affairs Specialist, you will perform regulatory affairs and quality system support activities associated with the manufacture and distribution of the Werfen product lines for U.S., Canada, and European Union.

Responsibilities

Key Accountabilities
  • Coordinates preparation, review and submission of product applications (510(k), BLA, Medical Device Licence Applications/Amendments, and Technical Documentation
  • Prepares and maintains Technical Files (Technical Documentation)
  • Reviews and approves quality system documents to determine compliance with SOPs, quality system and regulatory compliance, and industry standards
  • Reviews and approves significant changes (e.g. facility, product, process and labeling changes) for regulatory impact and domestic and international reporting requirements
  • Maintain regulatory product files of information submitted in support of domestic and international registrations
  • Coordinates field action and vigilance activities for Werfen product lines and notifies appropriate regulatory agencies, affiliates and distributors
  • Performs tasks and functions associated with product recalls/field corrections including preparing customer notifications, government submissions, status reports and recall effectiveness checks
  • Evaluates complaint and internal deviation report data to determine the need for Medical Device Reporting, field action or Biological Product Deviation reporting
  • Maintains compliance with Medical Device Listing requirements for Werfen products
  • Recognizes and elevates critical regulatory/compliance issues to RA management
  • Assists with the administration of regulatory and third-party inspections.
  • Performs other duties as assigned

Networking/Key Relationships
  • Works closely with other R & D staff members, quality control, quality assurance, customer service, shipping, sales and marketing staff.


Qualifications

Minimum Knowledge & Experience required for the position:

Education:
  • Bachelor's degree in science, engineering or related field required.
  • RAPS certification and membership, preferred

Experience:
  • Minimum of eight (8) years of experience in the US, EU, and international regulatory affairs within the medical device industry required.
  • Thorough knowledge of the product development and design control process.

Skills & Capabilities:
  • Sophisticated knowledge of and experience with FDA medical device and/or biologics regula-tions and guidance, Regulation (EU) 2017/745 or 2017/746 (IVDR) and guidance, Good Clinical Practices guidance, ISO 1348:2016 Quality System standards, ISO 14971:2019 Risk Manage-ment, and other applicable US and international regulations, guidances, and standards required.
  • Works precisely according to procedures, rules and regulations, has a passion for continuous improvement and quality.
  • Demonstrates the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside the Company.

Travel Requirements:

10%

About Instrumentation Laboratory Company

Instrumentation Laboratory Company (IL) is a global leader in the development, manufacturing and distribution of diagnostic solutions for Acute Care Diagnostics, with a focus on Critical Care and Hemostasis testing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. IL develops, manufactures and distributes diagnostic solutions including: critical care systems, hemostasis systems and information management systems. IL's products are used in hospitals around the world, including large hospital systems, independent hospitals and clinics, and reference laboratories. IL is headquartered in Bedford, Massachusetts, and has operations in Europe, the Middle East, Africa, Asia-Pacific, and Latin America.
Learn more about Instrumentation Laboratory Company
Size
1,000 employees
Industry
Healthcare
Net Income
$50 million
5 Year Trend
+5%
Revenue
$500 million
* Ladders Estimates

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