Role and Responsabilities:

In the context of the expansion of our services, we are looking for a talented profil in order to ensure delivery of Compliance and regulatory activities performed on the Medtech Delivery Platform,  including : Assessments on Technical documentation, Clinical aspects consistent to TCD completion  new registrations (IVDs Dossiers , technical documentation), submissions, interaction with health authorities on behalf of PLG customers. In details :

  • Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements and regional frameworks ( IVDR, 21 CFR 809 ) and others
  • Gain regulatory authority approval.
  • Support Customer on Notified Body conformity assessment on IVDR ( on technical Documentation, Full assurance system , Type examination ) and other related.
  • Provide on-going regulatory advice to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives.
  • Review full Technical documentation accompanying IVD products
  • Review tasks for, support and mentor IVD asoociates and specialists
  • Support medtech lead in identifying proper IVD development activities
  • Setting Ivd resources and development plan.
  • Seeting partnerships with IVD freelancers , labs and others
  • To produce and review SOPs relating to the IVD Lead  function.

Other :

  • To participate in training as required.
  • To provide in-house training as required for staff in the Regulatory Affairs group.
  • To contribute to the production of client documents and reports.
  • To support the Post Market Surveillance Medtech group in the production of Regulatory Authority and Ethics Committee documentation.
  • To liaise with other group companies on regulatory issues and to provide support for their activities in the regulatory field.
  • Contribute to follow up of the quality of service of regulatory partners working with the Platform/the Hub.
  • To represent PLG in regulatory associations, events and congress.
  • To comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives.

 

Skills

  • Bachelor’s or higher graduate degree in a science related field, or equivalent experience, such as acceptable level of  experience with proven track record.
  • Excellent organisational and time management skills
  • Ability to work well within a team and exhibit some degree of autonomy
  • Good interpersonal skills
  • Ability to make informed decisions
  • Process oriented with good attention to details
  • Effective oral and written communication skills
  • Good computer skills and the ability to learn appropriate software
  • Good understanding of safety database software, MS Word, MS Excel
  • Good English language and grammar skills (written fluency a must, verbal fluency preferred)
  • Good medical/therapeutic area knowledge and medical terminology preferred

In Vitro Diagnostic Lead