ThermoFisher Require RA Support Specialist
We’re a global biotechnology company dedicated to improving the human condition. Our industry-leading brands are found in nearly every life sciences lab in the world, including innovative instrument systems under the Applied Biosystems and Ion Torrent names. We’re also responsible for a broad range of reagents with our Invitrogen, GIBCO, Ambion, Molecular Probes and Taqman products. With approximately 3,900 patents and exclusive licenses, we’re home to one of the largest intellectual property estates in the life sciences industry.
Post : RA Support Specialist I
- Responsible for the coordination, evaluation and implementation of LPD’s regulatory strategy and compliance programs through the review, consultation, training and support of each discipline (Engineering, Operations, Quality, Sales, Sourcing etc) to fulfill their business goals in a compliant manner.
- Responsible for supporting a Regulatory Affairs network of people and resources in LPD to provide general regulatory support in the regions and time zones where LPD facilities operate with additional review and consultation for more detailed regulatory needs from centers of compliance excellence.
- Supports an effective interface between the respective disciplines and 3rd Party regulatory agencies (UL, CSA, TUV, Notified Bodies, FDA, ISO registrars, etc) and ensures this interaction follows the established best practice model for the division.
- Provides review, consultation and support for regulatory agency communications for LPD (e.g. FDA, EU Competent Authorities, China SFDA, etc).
- Should have a working knowledge of the applicable standards and regulations that apply to LPD (product safety standards like IEC 61010-1, EMC standards, applicable regulations like the RoHS, REACH and the F-gas regulation etc) so that that RA team can disseminate and filter this information to the respective disciplines inside LPD and the regulatory agencies that LPD works with to establish a consistent compliance approach.
- Participates in product reviews and ensures that the RA team provides a compliance review of each stage gate review for both internal product designs or changes and OEM branding projects.
- Responsible for reducing product liability while driving towards achieving our 20:20 vision of world class product compliance by 2020.
- Must support and help effectively manage any identified non-conformity or product liability discovery or incident as assigned by the RA Support Manager.
- Provides support to customers relative to compliance issues.
- Act as a change agent for improvement initiatives
- Perform all job duties in a safe manner and obey all safety policies and procedures
- Perform as a Role Model Leader, acting in compliance with the Thermo Fisher Code of Ethics and the 4-I Values (Integrity, Intensity, Involvement and Innovation).
- Perform all job duties within ISO standards, regulatory or statutory requirements.
Job ID: 50569BR
Industry Type: Pharma/ Biotech/Clinical Research
Fuctional Area: RA Support
End Date: 4th July, 2017
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