Regulatory Affairs Specialist in Portsmouth, United Kingdom at Pall

Date Posted: 1/24/2018

Job Snapshot

Job Description

Job ID: MED001439

About Us

Pall Corporation is a global leader in high-tech filtration, separation, and purification, serving the diverse needs of customers across the broad spectrum of life sciences and industry.



Pall Life Sciences provides cutting-edge products and services to meet the demanding needs of customers discovering, developing and producing biotech drugs, vaccines, cell therapies and classic pharmaceuticals. Pall offers advanced medical technologies, which are often a patient’s last line of defense from dangerous pathogens. Pall’s food and beverage products provide critical protection from contaminants during various manufacturing steps.



Pall Industrial serves a diverse range of customers in the microelectronics, aerospace, fuels, petrochemical, chemical, automotive, and power generation industries. Pall is a key supplier to the innovative and demanding semiconductor and consumer electronics industries, and provides filtration products used in critical applications on commercial and military aerospace vehicles. Pall products are key to the reliability of industrial equipment. Pall’s engineered solutions help municipal and industrial customers address mounting water quality, scarcity and demand issues, and help energy companies maximize production and develop commercially successful next generation fuels.



Headquartered in Port Washington, New York, Pall has offices and plants throughout the world.



To learn more about Pall, please visit www.pall.com/green.



Description

Position Summary:

Provision of Regulatory Affairs documentation for Pall Medical products in EMEA to meet legal and regulatory requirements.

Main Duties:
  • Compilation and maintenance of Technical Files for Pall Medical products to meet the Medical Devices Directive.
  • Submission of Technical Files to Notified Bodies for review and approval.
  • Coordination of the Risk Management process for Pall Medical products to ensure compliance with Regulatory requirements.
  • Coordination and maintenance of an effective post-market surveillance system for Pall Medical products to meet the requirements of the Medical Devices Directive.
Other Duties:
  • To assist colleagues in Pall Medical European Regulatory Affairs as directed by the Line Manager.
  • To participate in and support activities associated with Pall Medical objectives.

Job Requirements



Qualifications

Position Competencies:
  • Knowledge and Key Skills
    • Excellent oral and written communication 
    • The ability to present technical, product and regulatory information clearly and concisely
    • Good attention to detail
  • Essential Qualifications/Education
    • Bsc. Degree in Biological Sciences
  • Essential Previous Experience
    • 5+ years experience in a medical devices / life sciences industry in a regulatory or technical field
    • Knowledge of ISO13485 is preferred


Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% over 20 years.

At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.