Senior Regulatory Affairs Specialist

My client, a forward-thinking medical device company at the forefront of bioelectronic medicine. Their mission is simple, they're set to revolutionise healthcare by developing cutting-edge therapies for individuals battling chronic diseases. With their breakthrough, they have been granted the Breakthrough Device Designation by the United States FDA, enabling accelerated market access for devices addressing life-threatening or irreversibly debilitating conditions.

Senior Regulatory Affairs Specialist

As the Senior Regulatory Affairs Specialist, you will serve as the regulatory expert responsible for guiding the development and launch of an innovative medical device system. Your role involves collaborating with international regulatory consultants to enhance the organisations global regulatory strategy. You will closely coordinate with R&D, clinical, market access, and quality teams to ensure adherence to regulatory and legal requirements for successful market authorisation across the EU, USA, and other regions. As the primary point of contact with competent authorities, notified body, EU expert panel, and FDA, you will oversee the preparation and follow-up of FDA pre submissions, CE-mark dossiers, and other regulatory submissions, taking ownership of these critical processes.

Senior Regulatory Affairs Specialist Responsibilities:

• Spearhead the development and execution of the regulatory strategy to secure approvals from regulatory agencies such as the FDA and CE-marking, ensuring continuous compliance across the product lifecycle
• Act as the primary point of contact for regulatory submissions, reporting, and follow-ups with Competent Authorities, FDA, Notified Body, and other regulatory entities
• Lead the coordination, preparation, and submission of regulatory documents, ensuring accuracy and completeness
• Offer regulatory guidance and assistance for post-market surveillance activities, including the management of adverse event reporting and product complaints
• Stay updated on regulatory changes and evolving standards that may impact the product portfolio, proactively integrating necessary adjustments and ensuring compliance

Senior Regulatory Affairs Specialist Responsibilities:

• Possess an academic background in a relevant discipline, such as science, medicine, or pharmacy, coupled with a keen interest in (medical) technology
• Demonstrate a minimum of 5 years of recent and proven experience in Regulatory Affairs within the medical device industry
• Showcase firsthand experience in securing regulatory approvals for medium-risk or high-risk medical devices in both the EU and/or USA markets
• Exhibit an analytical mindset and exceptional writing skills, coupled with the ability to structure tasks effectively and independently initiate projects

As the Regulatory Affairs Specialist, you'll pioneer transformative therapies for chronic diseases like. You'll navigate complex regulatory landscapes, ensuring devices reach those in need swiftly. This role offers a chance to make a tangible difference worldwide, contributing to a transformative vision in healthcare. If this opportunity is of interest, please apply with an up to date CV right away.