Regulatory Compliance Leader
GE Healthcare Bio-Sciences AB / Kemiingenjörsjobb / Uppsala
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hela Sverige Role Summary:
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 and 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.
Essential Responsibilities:
Support the development of new products within the Life Science business with focus on chemistry
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
Supporting the Operations Leaders within the Product and Technology compliance team to set up strategies
Qualifications/Requirements:
Bachelors' Degree in Chemistry or related discipline (or equivalent knowledge/experience)
Strong working experience
Experience with working with Product regulations, QA/RA, other regulatory areas or experience with GEs chemical product portfolio and an interest to learn about regulatory compliance
Ability to analyze requirements/regulations and create efficient solutions
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
Desired Characteristics:
Knowledge around the Life Sciences portfolio
Knowledge around environmental regulations, e.g.
REACh (Registration, Evaluation, Authorization and restriction of Chemicals)
CLP (Classification, labelling, packaging)
Animal origin (EC1069/2009 and USP VI)
BPR (Biocidal Products Regulation)
TSCA (Toxic Substances Control Act)
RoHS and WEEE directives
Experience with authorities such as Environmental Protection agencies, e.g. Swedish Chemicals Agency, ECHA (The European Chemicals Agency), EPA (Environmental Protection Agency)
Publiceringsdatum2019-01-28Så ansöker duSista dag att ansöka är 2019-02-15
Klicka på denna länk för att göra din ansökanFöretagGE Healthcare Bio-Sciences AB
KontorsadressBjörkgatan 30
Jobbnummer 4579875
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