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Medical Device Regulatory Affairs

Medical Device Regulatory Affairs

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Medical Device Regulatory Affairs

  • Location:

    England

  • Sector:

    Medical Device

  • Contact:

    Harry Reeve

  • Salary:

    €50 - €70 per hour

  • Job type:

    Interim/Contract

  • Contact email:

    harry.reeve@msipharma.com

  • Job ref:

    VR/04176_1663236821

  • Published:

    17 days ago

  • Duration:

    12 months

  • Startdate:

    ASAP

MSI Pharma are looking for a freelancer to join a leading Medical Device company in Switzerland.

In this role, typical activities may include:
Directing and coordinating activities concerned with medical device submissions and approvals to government regulatory agencies and notified bodies.
Providing guidance to project team members regarding regulatory compliance issues by providing independent regulatory guidance, regulatory impact assessments and support for strategic planning and compliance activities.
Overseeing the preparation and maintenance of regulatory files
Preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
Reviewing and approving proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.
Working with team members and commercial partners, provide RA guidance to New Product Development projects
Interpreting medical device regulation (MDR) requirements

Qualifications
A minimum of a Bachelors degree with 3-5 years of experience in regulatory affairs is required.
Practical experience in a Medical Device Regulatory Environment is required.
Knowledge of US and European regulatory processes is required.
Experience with 510(k) submissions and/or Class II Technical files is required.
Experience working as a member of a team in a timeline-driven environment with limited supervision is required.
Demonstrated track record of developing and executing global regulatory strategies that align with business deliverables is required.
Experience with Medical Device Regulation (MDR) is preferred.
Experience in change management is preferred.
Knowledge of international medical device requirements (China, Japan, Australia, Brazil, Russia, etc.) is preferred.
Excellent written, verbal communication and presentation skills.
The position is based in Oberdorf switzerland