Job Description

Job Purpose

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Support the Product Safety Officer with respect to authority reporting, vigilance and Field Safety Corrective Actions.

Support the Post Market Surveillance team with regard to data collection and report preparation.

Main tasks and responsibilities:

Update and maintain all relevant procedures related to product safety, vigilance in accordance with applicable laws and regulations Support the assessment of regulatory changes and industry best practices to enhance safety measures Supports Audits and inspections of Notified Bodies and Regulatory Agencies Support the timely response and assessment of product safety issue input from customer complaints, CAPAs (Corrective and Preventive Actions), NCRs (Non-Conformance Reports), Clinical research and other feedback mechanisms Ensure patient safety, and implementation of necessary measures Support activities for Corrections & Removal e.g. Safety Board as defined Participate in cross-functional safety boards in response to potential product safety issues with products already on the market Support reporting to the authorities in accordance with the appropriate country laws and regulations and as defined in the related procedures Support product recalls and field safety corrective actions when necessary Develop and deliver training programs on product safety and vigilance to relevant staff Support data collection for management review

Requirements needed

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Knowledge of ISO 13485, QSR, FDA 21 CFR 820, ISO 14971, EU medical device Regulation MDR 2017/745, MDSAP, and all other applicable standards and regulation Knowledge of root cause analysis techniques Fluent (written and spoken) in English Experience in communication with notified bodies and authorities nice to have Proven ability to understand external requirements and translate them to internal procedures

Education / Experience

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Technical or natural scientific graduate degree (FH/Uni/ETH) 2-3 years professional experience in Regulatory Affairs and/or Quality Management of medical devices

Personal Attributes

Excellent analytical, problem-solving, and decision-making skills. Able to make decisions under stress based on available input and defend safety relevant decisions in front of upper management and auditors Ability to build and maintain excellent business relationships Team player with open and positive attitude as well as a high level of integrity and commitment


All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

Employment Type:

Contract

Alternative Locations:

Switzerland : Basel

Travel Percentage:

0%

Requisition ID:

19148