RA Manager

看过: 140

更新日: 26-11-2025

位置: Mechelen Antwerp

类别: IT-软件行政/文书/助理

行业: Computer Software Medical Devices

水平: Mid-Senior level

工作类型: Full-time

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工作内容

Your main accountabilities and responsibilities include:

You develop and execute global regulatory strategies for assigned projects while focusing on the main markets, i.e. EU and US. This will include the creation, review and/or approval of documents of the design control process, development of the technical file and summary of technical documentation.
You are responsible for CE marking and supporting the US submission and monitoring submission timelines and timely responses to requests by notified bodies or competent authorities. It also includes constant development/ improvement of product development and RA processes.
You collaborate with the local RA Manager in International product registration.
You monitor legislative environment and define and maintain an overview of the regulatory requirements and changes in the areas if applicable.
You assess, approve and release communication material (IFU, leaflets, brochures).
You train and assist other departments to ensure continued compliance and timely market release.
You develop and execute regulatory strategies for assigned development projects
You support product development in cross functional teams
You create, review and/or approve documents of the design control process
You are accountable for regulatory compliance
You assess, approve and regulatory implement change requests
You review and approve product related labeling and marketing material

Your profile:

You have a Bachelor’s Degree (BS) required or Master’s Degree (MS)
You have minimum 3-5 years’ experience in regulatory affairs within the Medical Device Industry required, experience in standalone software medical devices is preferred.
You have a strong knowledge of medical device legislation US, EU, AUS and CAN and corresponding guidelines
Strong knowledge of quality system requirements specifically ISO 13485, 14971, 62304, 62366 and FDA’s 21 CFR Part 820
Knowledge of product development processes in medical device industry
Experience in preparation for and participation in notified body audits and FDA inspections
Experience in managing cross functional projects

Our offer:

Attractive salary package with interesting extra-legal benefits (meal vouchers, internet@home, train subscription, iPad, …)
An informal and collaborative work environment, supporting individual growth in talent and leadership
An internationally-oriented working atmosphere
A clear onboarding process with focus on continuous learning: internal, external and on-line seminars, attending international conferences
A challenging leading edge and inspiring work environment which contributes to human health and convenience

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