Conformity Assessment Procedure Specialist (f/m/d) – IVDR (null)

Aufgaben Overall responsibility for up to date compliance to the
assigned IVD conformity assessment scheme and applicable Standards
Create among MHS Top Management and MHS employees awareness for the
essentials of the conformity assessment scheme and related changes
Identifies regulatory risks and create awareness among relevant
managers and process owners Supports process owners and
certification bodies as well as project leaders (e.g. for
digitization projects) to find the most efficient and effective
solutions in compliance with the requirements of the conformity
assessment scheme and applicable standards Reviews changes in
scheme relevant processes and QM documents for regulatory
compliance in a documented manner Performs spot checks and internal
audits of the conformity assessment scheme Analyses quality
problems for risks of non-compliance to regulatory requirements
Training on overall conformity assessment scheme and how individual
processes relate to the scheme Where appropriate, attendance at
notification and accreditation audits in respect to conformity
assessment scheme including follow-up of related corrective
actionsQualifikationen Possess at least a University Degree
specializing in engineering/biology or appropriate science area or
related discipline At least 5 years of management experience in the
field of the regulatory scheme or its preceding regulation
Demonstrated experience in project management Sound knowledge in
medical devices regulatory requirements and quality management
Strong working knowledge of regulatory framework of IVDD/IVDR,
MDSAP Strong working knowledge of quality and conformity assessment
standards like ISO/IEC 17065, ISO 17021, ISO 17025, ISO 13485.
Ability to interpret regulations also from a technical as well as
legal perspective Ability to quickly assimilate and assess new
information and develop plans to react to it Able to prioritize and
perform required follow up Good supervisory, management and
networking capabilities Strong analytical, problem solving,
attention to detail and process improvement skills Good command
over English and preferably German Must possess strong work ethic
and excellent client service skills to ensure effective, responsive
client interaction (internal and external) Excellent verbal and
written communication and presentation skills Able to work well
under pressure to handle crisis situations and balance several
tasks simultaneously Proficiency in Microsoft applications Must be
confident, highly efficient, and self-motivated Must be personable
and work well independently, as well as in a team and matrix
environment Strong appreciation of different cultures