Regulatory Affairs III in Oberdorf

veröffentlicht
Kontakt
Barbara Sorce, Basel Professionals Health Care & Life Sciences
Jobtyp
Contract
jetzt bewerben

job details

veröffentlicht
Ort
Oberdorf, Nidwalden
Sektor
Life Sciences
Jobtyp
Contract
Referenznummer
18045
Kontakt
Barbara Sorce, Basel Professionals Health Care & Life Sciences
Telefon
058 201 55 50

Stellenbeschreibung

For our client, a medical devise in Oberdorf, we are looking for a Specialist III, Regulatory Affairs  
  • Start:asap
  • Length until 31.12.2023
  • Location: Oberdorf 
Your Responsibilities: 
  • Support MDR compliance execution work by creation/update of Technical Documentation of existing devices to comply with MDR requirements
  • Identify, create and/or update reference documents for technical documentation including, but not limited to design and risk documents, verification/validation documents, standards conformance, Clinical Evaluation Reports, General Safety and Performance (GSRP) Checklists, Table of Contents, Declaration of Conformity, and labeling.
  • Provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches inclusive of site transfer activities.
  • Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.
  • As required, coordinate with various Technical file cross functional teams to make sure that data is aligned across the spectrum.
  • Identify and adhere to policies, procedures and work instructions which support technical documentation activities
  • Working with cross-functional teams to obtain relevant information and subsequent review of submission content as needed; assist in review of international product technical documents, marketing and labeling materials
  • Align and create technical documentation according to OneMD technical documentation structure proposed by the MDR team and/ or according to updated procedures by fulfilling RA deliverables according to project plan
  • Support for routing and implementation of the remediated documents in PLM systems
  • Support preparation of technical or design dossier documentation for submission to and review by Notified Bodies, as required
  • Provide support for preparation activities for MDR compliance including, but not limited to data cleansing and comparison, remediation and maintenance of existing Technical Documentations as instructed and assigned
  • Supporting team's daily operations of regulatory processes to ensure compliance with routine regulatory reporting obligations
  • Follow the quality standards and regulatory requirements
  • Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times
  • Resolving complex issues as they arise
 Your Profile:
  • Bachelor's (minimum 3 years’ experience) or Master’s (minimum 2 year of experience) Degree in engineering or life sciences is required; or Advanced Degree (PhD with 1-2 years of experience) is preferred.
  • 2-3 years of experience in European Medical device industry especially with regulatory, quality or engineering
  • Strong knowledge of
    • ISO 13485, QSR
    • Understanding of MDR requirements regarding required content of Technical Documentation (focus on ANNEX II of Regulation (EU) 2017/745)
    • MEDDEV and MDCG guidance documents applicable to Medical Devices products and processes
  • Reasonable knowledge of
    • FDA requirements
    • registration requirements in further global markets would be an asset
  • Strong understanding of Risk Management process, label and labeling, change management is desired
GERMAN LANGUAGE DESIRABLE BUT NOT NECESSARY, ENGLISH FLUENT MANDATORY. FLEX POLICY: 3 DAYS AT SITE, 2 DAYS HOME OFFICE