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Regulatory Affairs Specialist-EIS

3 months ago

Warsaw, United States TEPHRA Full time
Description:

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.

Responsibilities:

•Identify reference documents for technical documentation including, but not limited to design and risk documents, verification/validation documents, standards conformance, and labeling.
•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 regulatory bodies.
•Maintain information on worldwide regulatory requirements and the status of product registrations.
•Be responsible for adherence to timelines and ensure milestones are achieved.
•Report issues to the Customer and Our client management to ensure appropriate closure.
•Work with Our Client teams at offshore and at other geographies.

Qualifications:

Experience Required:

•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 Windchill)
•Proficient with MS Office applications such as MS Word, Excel.
•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 skills
•Organizational / planning skills
•Strong analytical skills
•Comfortable with using and facilitating a variety of problem solving methodologies
•Mentors and develops junior staff within the our Client's delivery organization
•Willing to work with offshore teams in remote locations

Education:

Bachelor of Engineering (Mechanical, Biomedical preferred) or Bachelor of Science (Biology or Chemistry)