Technical Planning Specialist

Global company

Key purpose of the role
Technical Planning Specialist Technical Planning Manager
This role has accountability to ensure the activities related to technical planning are performed accurately and timely. This role also has responsibility to contribute to the Planning team for compliance against the following requirements;
• EU Medical Device Directives (e.g. 93/42/EEC)
• REGULATION (EU) 2017/745 of the European Parliament and of the Council on medical devices.
Responsibilities among others are
• Assist in developing, maintaining and improving processes, procedures, forms and registers to enable the technical planning to run effectively and efficiently
• Responsible for Change management implementation including review of client change notices within timelines and implement change actions or transfer the actions appropriately to the related groups, primary Auditing, Technical Documentation Review and Certification staff
• Management of Change Notice database
• Finalise Client Information Form Assessments and recommend decisions and liaise closely with Sales and Certification staff to obtain required information and to plan work as required
• Review revisions of contracts for existing clients on a regular basis
• Manage incoming technical enquiries, as received by the coordinator responsible for the specific inbox.
• Review and approve Addition of products to scope or pass them on to TD assessors, Clinical or CA
• Set up cycles for Unannounced audits
• Monitor the regulatory environment related to NB designation
• Monitoring of Vigilance, decide on actions related to Vigilance reports
• Ensure that initial technical sampling is extended to include appropriate clinical sampling in collaboration with the clinical team and monitor adherence to the sampling rationale
• Responsible for to ensure timely processing of the Post Approval Follow-up.

Who are you
• The role holder should possess either an appropriate degree, college degree or other qualifications and/or experience in either Health Science, Engineering or Quality/Regulatory disciplines related to the Medical Device industry sectors
• Advantageous: experience in Quality Assurance and/or Regulatory Affairs in the Medical Devices industry
• Have a good knowledge the EU Medical Device Directives and Regulations
• Have at least 3 yrs Medical Device Industry experience, as well as conformity assessment experience with a Notified Body
• Must be able to demonstrate the capability to coordinate, plan, follow up
• Has a keen eye for detail and is focussed on delivering accurate and robust results within agreed timeframes
• Have proven skills for task management, managing scheduling, follow-up and data control for KPIs
• Fluent in English, written and spoken.
• You can live Stockholm, Halmstad or almost anywhere.
Please contact Erik Düring at Rekryteringsspecialisten for more information or to apply to this position.
Mobile: +46 708 999469