QA/RA Specialist Medical Device

À propos de l’offre d’emploi

ProductLife Group is growing and we are looking for the next member of the Medical Device international team :

RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO :

Quality:

• ◆ Drafting quality docs even in basic manner:
• ◆ SOP, WI templates
• ◆ Handling Non Conformities on processes and material
• ◆ Capability to handle CAPA entirely of part of it ( in case specify Capa handling skills)
• ◆ Support internal and external audits ( even related activities for preparation )
• ◆ CE marking approval support

Regulatory:

Coordinating activities in order to handle Technical Documentation aspects :

• ◆ Tech file support draft
• ◆ Sted handling
• ◆ Declaration of conformity (according to MDD and MDR)

Compliance activities

• ◆ Involvement approval processes:
• ◆ EU In country registrations (in case mention dfor which country you collaborate to proceed for registration
• ◆ FDA Premarket approval (510K) support
• ◆ MDSAP support preparation.

CANDIDATE’S IDEAL PROFILE:

ProductLife Group applies the principles of equality and diversity in the workplace and opposes all forms of discrimination.

HARD SKILLS

• ◆ Knowledge of standards ISO 13485 : 2016 / ISO 14971
• ◆ Knowledge of regulations MDD 93/42 – QSR 21 cfr 820

SOFT SKILLS

• ◆ Entrepreneurial spirit and proactive approach
• ◆ Organization, autonomy and ability to prioritize
• ◆ Proficient in English communication with Technical and non-Technical Stakeholders
• ◆ Ability to evolve and to be part in an international team

EDUCATION AND EXPERIENCE

• ◆ Graduation MSC or PHD in scientific matters (Engineering, Chemistry, Pharma…)
• ◆ At least 3/5 years of experience in medical Device field (or Strictly related)
• ◆ Experience in quality assurance and compliance activities
• ◆ Experience in regulatory affairs
• ◆ Experience with a PLM documentation system is highly appreciated

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