Senior Regulatory Affairs Specialist

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My shopper, a forward-thinking medical system firm on the forefront of bioelectronic medicine. Their mission is easy, they’re set to revolutionise healthcare by creating cutting-edge therapies for people battling persistent illnesses. With their breakthrough, they’ve been granted the Breakthrough Gadget Designation by the US FDA, enabling accelerated market entry for gadgets addressing life-threatening or irreversibly debilitating situations. Senior Regulatory Affairs Specialist Because the Senior Regulatory Affairs Specialist, you’ll function the regulatory professional chargeable for guiding the event and launch of an progressive medical system system. Your function includes collaborating with worldwide regulatory consultants to boost the organisations world regulatory strategy. You’ll intently coordinate with R&D, scientific, market entry, and high quality groups to make sure adherence to regulatory and legal necessities for profitable market authorisation throughout the EU, USA, and different areas. As the first level of contact with competent authorities, notified physique, EU professional panel, and FDA, you’ll oversee the preparation and follow-up of FDA pre submissions, CE-mark dossiers, and different regulatory submissions, taking possession of those crucial processes. Senior Regulatory Affairs Specialist Duties: Spearhead the event and execution of the regulatory strategy to safe approvals from regulatory companies such because the FDA and CE-marking, making certain steady compliance throughout the product lifecycle Act as the first level of contact for regulatory submissions, reporting, and follow-ups with Competent Authorities, FDA, Notified Physique, and different regulatory entities Lead the coordination, preparation, and submission of regulatory paperwork, making certain accuracy and completeness Provide regulatory steering and help for post-market surveillance actions, together with the management of hostile occasion reporting and product complaints Keep up to date on regulatory adjustments and evolving requirements which will affect the product portfolio, proactively integrating essential changes and making certain compliance Senior Regulatory Affairs Specialist Duties: Possess an instructional background in a related self-discipline, resembling science, medicine, or pharmacy, coupled with a eager curiosity in (medical) technology Reveal a minimal of 5 years of current and confirmed expertise in regulatory affairs inside the medical system business Showcase firsthand expertise in securing regulatory approvals for medium-risk or high-risk medical gadgets in each the EU and/or USA markets Exhibit an analytical mindset and distinctive writing abilities, coupled with the flexibility to construction duties successfully and independently provoke tasks Because the Regulatory Affairs Specialist, you may pioneer transformative therapies for persistent illnesses like. You will navigate advanced regulatory landscapes, making certain gadgets attain these in want swiftly. This function affords an opportunity to make a tangible distinction worldwide, contributing to a transformative imaginative and prescient in healthcare. If this chance is of curiosity, please apply with an updated CV instantly.
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