Regulatory Affairs Manager Medical Devices

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We have a new opportunity for a regulatory affairs expert with prior experience in medical devices to support the team in creation and maintenance of Technical Documentation for CE marked products (implants and instruments) according to with MDR compliance framework.

Tasks:

Support preparation of technical documentation and develop dossier documentation for submission to and review by Notified Bodies, as required (both MDD and MDR)

- Provide regulatory support for New Project Development projects as assigned with focus on CE marking (under MDD as well as MDR) and US requirements (510(k))

- Provide regulatory support for Life Cycle Management project as assigned

- Manage data cleansing and comparison, remediation and maintenance of existing Technical File documentation as instructed and assigned.

- Perform Regulatory Change assessments as assigned,

- Perform Labeling and Promotional Material Reviews as assigned

Requirements:

Strong experience in Medical Device Industry and Regulatory Affairs.

Understanding of MDR requirements regarding required content of Technical Documentation

(focus on ANNEX II of Regulation (EU) 2017/745)

Understanding requirements of current Council Directive 93/42/EEC

Familiarity with Technical Documentation structure according to STED and as required by Medical Device Regulation 2017/745

experience with PLM systems such as Windchill PLM, Agile e6 PLM,

Technically versed in computer software such as MS Word, Powerpoint.