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  • Functie titel:

    RA & Compliance Manager

  • Sector:

    Medical Devices

  • Job ref:

    46170

  • Start datum:

    2021-07-01

The Company

Being one of the most innovative companies in the healthcare industry with over 400 exciting and groundbreaking products designed to improve the quality of life of all of it's customers. Operating both B2B and B2C, their influences on the healthcare sector as a whole have been immense in it's 100+ years of operations.

Role Description

As Regulatory affairs and product compliance manager your job is to ensure that products of Consumer Health Business portfolio comply with external regulations and standards and with company product safety & compliance policies. You will be guiding the business through the borderline and rapidly changing regulatory landscape.

Responsibilities

· Develop global regulatory strategy, and if needed connect to regulatory SMEs

· Participate in and advise cross-functional teams on applicable regulations, requirements, and standards, as applicable to products in scope

· Create product regulatory plan and support creation of standards and compliance plans and labeling plans

· Elicit regulatory requirements

· Review development documentation and plans to ensure that the information required for submissions and product compliance is adequate
 

Requirements

· A degree in engineering combined with a strong interest in Regulatory Affairs and Compliance.

· a proven record of accomplishment in product development and Safety & Compliance domains in international, multi-disciplinary development projects

· Project management skills

· Fluent in English, both verbal and in writing

Neem contact op

SIRE® LIFE SCIENCES B.V.

Staten Bolwerk 1
2011 MK Haarlem
The Netherlands
+31 (0) 20 658 9800

SIRE® STAFFING SOLUTIONS B.V.

Keizersgracht 440A
1016 GD Amsterdam
The Netherlands
+31 (0) 20 658 9804