Regulatory Affairs Specialist-EIS : Medical Device & Regulations
Posted on: November 22, 2021
The candidates will work with client & Our Client's teams to
deliver best in-class solutions for regulatory submissions. Assist
in the creation of technical documentation (technical files and
design dossiers) for Spine products that will meet the requirements
of the new Medical Device Regulation (MDR) in the European Union.
The requirement is for 3 Regulatory Affairs Specialist.
--- Identify reference documents for technical documentation
including, but not limited to design and risk documents,
verification/validation documents, standards conformance, and
--- Identify and adhere to policies, procedures and work
instructions which support technical documentation activities.
--- Provide support for Clinical Evaluation Reports including
references to required documentation.
--- Align technical documentation according to OneMD technical
documentation structure proposed by the MDR team.
--- Prepare technical documentation for submission to and reviewed
by Notified Bodies, as required.
--- Facilitate worldwide product registration activities by
compiling appropriate dossiers, submissions and responses to
--- Maintain information on worldwide regulatory requirements and
the status of product registrations.
--- Be responsible for adherence to timelines and ensure milestones
--- Report issues to the Customer and Our client management to
ensure appropriate closure.
--- Work with Our Client teams at offshore and at other
--- Strong knowledge of EU Medical Device regulations and guidance
documents as well as relevant standards.
--- Experience of Tech File and technical Documentation for
submission to notified bodies
--- Ability to work with cross-functional team members including
(but not limited to) R&D, Quality, Labelling, Sterility,
Medical and Clinical.
--- Experience in working with PLM systems (i.e. Agile and
--- Proficient with MS Office applications such as MS Word,
--- Excellent communication and inter-personal skills.
--- Ability to manage multiple tasks and be detail-oriented.
--- Knowledge of German is a plus
Generic Managerial Skills:
--- Highly developed negotiation and influencing skills
--- Highly developed and proven written and oral communication
--- Organizational / planning skills
--- Strong analytical skills
--- Comfortable with using and facilitating a variety of problem
--- Mentors and develops junior staff within the our Client's
--- Willing to work with offshore teams in remote locations
Bachelor of Engineering (Mechanical, Biomedical preferred) or
Bachelor of Science (Biology or Chemistry)
Keywords: Tephra, South Bend , Regulatory Affairs Specialist-EIS : Medical Device & Regulations, Healthcare , Warsaw, Indiana
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