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Product Claim Documentation Specialist

Employer
Proclinical Staffing
Location
Copenhagen Municipality, Denmark, Copenhagen
Salary
Negotiable
Start date
19 Aug 2019
Closing date
2 Sep 2019

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Job Details

An international consulting company is advertising a vacancy for a Product Claim Documentation Specialist to their office in Denmark. The organisation complete compliance programs and introduces new products to the global market. This position is an exciting opportunity to gain bring skills and experience to a position in the regulatory and engineering fields. Please note that this is a contract role, lasting for six months.

Job Responsibilities:

  • Conducting initial documents for legacy products, where initial product claims (benefits and features/requirements etc.) are documented.
  • Reviewing large amount of clinical data and technical content of product instruction for use (IFU) and joining the information into a single document that depicts the main features and benefits of a device.

Skills and Requirements:

  • Clinical understanding and capable of extracting product benefits and requirements from clinical studies.
  • Experience with:
    • handling large amount of clinical data
    • technical documentation such as design input requirements, Material Lists, technical device/part drawings
    • working with medical devices, preferably implants (class III)
    • ISO 13485
  • Have the technical competencies to be able to understand our products and how they function in a clinical environment.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Daniel Nesje at +44 203 870 6797 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

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.

#LI-DN2

#RegulatoryAffairs

Company

At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.

Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives. 

ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating. 

Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.

 

Company info
Website
Telephone
0800 988 4437
Location
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom

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