Regulatory Affairs Specialist in Hoegaarden, Belgium at Pall

Date Posted: 6/22/2019

Job Snapshot

Job Description

Job ID: LIF004216

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 https://www.pall.com/en/about-pall.html.


Description

As part of the Biotech Regulatory Affairs team, the Regulatory Affairs Specialist enables the adoption and use of Pall products, including single use technologies and filtration devices in the Biotechnology industry by supporting R&D, Engineering, Sales, Supply Chain, Marketing, and other internal functions on issues related to quality and regulatory compliance.   They will advise project teams on subjects such as customer requirements, material compliance, labeling requirements, shelf life, and sterility to assure products meet requirements for global sale.  The Regulatory Affairs Specialist also provides daily support to customers requesting regulatory and quality documents for product approval.   

Key Responsibilities:
  • Approve single use parts and systems in the component management system (ACMS); 
  • Support and improve ACMS by aligning and maintaining quality and technical data, evaluating supplier data for acceptable compliance, and sourcing missing data;  
  • Support shelf-life alignment between manufacturing sites, and develop and support mitigations related to shelf-life and gamma sterilization;  
  • As requested, participate on teams to develop robust processes leading to regulatory compliance and continuous improvement; 
  • Contribute to development of Biotech Regulatory Affairs policies and procedures;
  • Evaluate and interpret new and changing regulations and legislative requirements to determine impact on products and propose strategies;
  • Investigate and assist resolution of compliance problems and questions;
  • Support adoption of BPOG recommendations as related to change management, customer notification, and supplier management;
  • Provide customers with direct support on material compliance requests, questionnaires, and quality agreements;  
  • Maintain regulatory knowledge by attending educational workshops; reviewing professional publications; establishing networks, and benchmarking industry practices;
  • Support and expand use of DBS tools to drive RA process improvements.  

Job Requirements



Qualifications

Knowledge / Skills / Abilities:
  • Bachelor / Master Degree in Life Sciences or Chemistry discipline;
  • 1 – 3 years experience in biotechnology industry / GMP environment;
  • Working knowledge of regulations and requirements for Biotechnology;
  • Proven ability to handle multiple priorities; 
  • Good oral and written communication skills; fluent in English and Dutch;
  • Ability to work in a global environment, work in teams, and develop good peer relationships;
  • Willingness to travel for training and projects as required (Europe and U.S.);
  • Demonstrated analytical thinking and problem-solving skills leading to good decision making;
  • Action oriented, results driven, and motivated to perform at a high level, with the ability to balance QARA, technical and business considerations; 
  • Excellent computer based skills, including Microsoft Office (Excel) and aptitude for learning ACMS and other software platforms.




Diversity & Inclusion
At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.




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 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 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.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.