Statistical Validation & Verification Specialist job in Zug, Switzerland

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Contract

Discipline: Validation

Location: Switzerland

This vacancy has now expired. Please see similar roles below...

Proclinical are recruiting a Statistical Validation & Verification Specialist for a medical technology and devices organisation. This role is on a contract basis with the ability to work remotely from anywhere in Europe.

Responsibilities:

Serve as the main point of contact between regulatory affairs and any other divisions, fostering efficient communication and cooperation.
Offer technical guidance concerning V&V needs for medical procedures, materials, equipment and strategies.
Uphold technical file/DHF documentation in line with pertinent regulatory standards.
Support FDA PMA proposal evaluation and replies to guarantee adherence to regulatory needs.
Execute and comprehend suitable standards and guidelines to assure ongoing product and systems compliance.
Cooperate with internal teams to produce and uphold risk management documentation.
Assist with change requests, corrective and preventive procedures to develop the quality and safety of the medical devices.
Other duties to be assigned to this role.

Key Skills and Requirements:

Educated to a degree level in an engineering, statistics or similar discipline.
Familiarity with statistical strategies, sample size calculation and their implementation to medical device V&V actions.
Comprehension of the US code of federal guidelines and MDR 2017/745.
Acquaintance with FDA PMA proposals and regulatory compliance.
Prior involvement in risk management documentation and procedures.
Project management abilities.
Capable of working well independently while under minimal supervision.
Works well with others.
Communication skills both verbally and in writing.
A high attention to detail.
Able to think analytically.

If you are having difficulty in applying or if you have any questions, please contact Joshua Bye at +44 20 3854 1052 or j.bye@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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