Senior Regulatory Affairs Specialist

☞ Randstad Switzerland

View: 115

Update day: 25-04-2024

Location: Lausanne Vaud VD

Category: Legal / Contracts

Industry: Staffing Recruiting

Position: Associate

Job type: Full-time

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Job content

For our client,a growing company in the medical devices field, we are looking for a:

Senior Regulatory Affairs specialist

Location:Canton of Vaud

Contract: Temporary

Contract start date: Summer 2022

Contract end date: February 2023

The Senior Regulatory Affairs specialist will be responsible for the development and implementation of the regulatory strategy (as applied to project, process, and/or product) and partners with internal stakeholders (e.g., regions) to align on an optimized regulatory strategy in order to achieve business objectives.Perform regulatory submission/approval activities for specific complex Diagnostic Imaging (DI) products, with focus on software and SaMD.

Your Main Responsibilities
  • Define regulatory requirements necessary for regulatory approval of products. Complete regulatory assessments needed to support projects and provide direction to project teams on regulatory agency expectations and guidelines to support new product development and product modifications. Provide direction on application of external standards to project team.
  • Develop and execute EU, Notified Body, FDA, TGA, and Health Canada product submission strategies. Work with the international regulatory team to develop, document, and communicate registration deliverables and strategies to the product development or project team.
  • Maintain regulatory documentation in accordance with departmental practices and quality system requirements. Support audits and participate in CAPAs, process improvements, and other special projects as needed. Maintain up-to-date training with SOPs, WIs, regulations, and applicable guidance documents.
Your Profile
  • BS degree in Science or Engineering
  • Minimum of 5 years experience in Regulatory Affairs or similar field.
  • Minimum of 4 years medical device or related industry experience, including EU CE Mark submissions, 510(k) submission experience, Health Canada submissions, and international market submissions.
  • Expertise in software life cycle management, cybersecurity and data protection related to Medical Devices.
  • Working knowledge and experience with quality systems regulations and guidelines, relevant ISO standards, GMP,Medical Device Regulations (MDR), FDA, TGA, and Canadian regulatory requirements.
  • Demonstrates planning and organizational skills.
  • Strong writing skills in the form of high quality regulatory submission documents.
  • Requires intense concentration in order to accurately assess compliance to applicable regulations for medical device manufacturers and comparing them to processes, policies, procedures and other quality related documentation, which may involve point-by-point comparisons.
  • The work is detail oriented, often with multiple priorities.
  • The environment is deadline sensitive. Frequent high-pressure situations.
  • Travel requirements are minimal. Travel about 2-3 times annually for 2-3 days duration each trip.
Please note that we will be only considering applications from candidates with a valid work permit or EU - EFTA citizenship.
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Deadline: 09-06-2024

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