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

Publish Date

10 May, 2022

Spontaneous Application

In Vitro Diagnostic Lead

New opportunities open up across PLG all the time. If nothing matches right now, send us a spontaneous application: we will keep you in mind for what comes next.

Apply