Regulatory Compliance Leader
GE Healthcare Bio-Sciences AB / Kemistjobb / Uppsala
2016-11-09
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hela Sverige Role Summary/Purpose
We are seeking a person with chemistry background that will globally support our Chemistry and Consumable products to ensure Compliance to applicable regulations for defined markets.
Essential Responsibilities
This role is responsible for evaluating products to ensure they will meet applicable regulations and standards including product environmental regulations, and will be a key contributor to R&D during the development process for design to compliance. The Regulatory Compliance leader will interpret the impact of new or changing requirements and recommend compliance strategies to the product teams, to avoid disruption of trade or impact customers.
Duties include (but are not limited to):
Support the development of new chemical and consumable products within the Bioprocess and Lab Service business.
Core team member for New Product Introduction (NPI) projects to secure compliance to relevant regulations to get market access.
Review change requests/orders to ensure that Compliance requirements are met and maintained.
Maintain awareness of applicable regulations, and monitor activities related to changes to regulations.
Participate/support Product Stewardship Projects.
For questions regarding this position please contact Carl Lindner, Product Stewardship Manager,
carl.lindner@ge.com or: +46(0)706128099.
Qualifications/Requirements
Bachelors' Degree in Chemistry or closely related discipline
Significant years' relevant working experience
Proven experience with working with Chemical Regulations
Ability to analyze requirements/regulations and create a manageable design solution
Demonstrated ability to pursue tasks to completion, results oriented
Strong communication, interpersonal, analytical, and problem-solving skills
Process and detail-oriented, including strong organizational skills and ability to prioritize
Self-motivated with ability to handle a large and varied workload simultaneously, to multitask and to work independently
Ability to interface effectively with different functions throughout the organization
Experience in cross functional team communications, influencing skills and ability to gain buy-in for initiatives.
Extractable and leachable requirements for Single Use consumables
21 CFR Part 170 Food Additives and Food Contact Substance Notification Program
Experience with REACH (Registration, Evaluation, Authorization of Chemicals)
CLP (Classification, labelling, packaging)
Animal origin (EC1069/2009 and USP VI)
Desired Characteristics
Experience with
BPR (Biocidal Product Regulation)
TSCA (Toxic Substances Control Act)
Experience with BioPharmaceutical manufacturing.
Knowledge around product environmental regulations such as RoHS, WEEE directives
Experience as a Compliance or Regulatory engineer
Masters degree in Chemistry or other closely related fields
Familiar with Design and Development in ISO 9001.
Experience with authorities such as ECHA (The European Chemicals Agency), EPA (Environmental Protection Agency)
Sterilization requirements for Single Use consumables
Biocompatibility requirements and standards
Experience from GMP and GLP regulated environment, including clean room
What do you envision for your future? At GE Healthcare, we strive to see life more clearly. Our
"healthymagination" vision for the future invites the world to join us on our journey as we continuously
develop innovations focused on reducing healthcare costs, increasing access and improving quality and
efficiency around the world.
We are an $18 billion unit of General Electric Company (NYSE: GE), employing more than 52,000 people
worldwide and serving healthcare professionals in more than 100 countries. We believe in our strategy -
and we'd like you to be a part of it. As a global leader, GE can bring together the best in science,
technology, business and people to help solve one of the world's toughest challenges and shape a new age
of healthcare.
Something remarkable happens when you bring together people who are committed to making a difference -
they do!
At work for a healthier world.
Publiceringsdatum2016-11-09Så ansöker duSista dag att ansöka är 2016-11-27
Klicka på denna länk för att göra din ansökanFöretagGE Healthcare Bio-Sciences AB
AdressGE Healthcare Bio-Sciences AB
Björkgatan 30
75184 Uppsala
KontorsadressRapsgatan 7
Jobbnummer 3152475
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