Senior Regulatory Affairs Specialist

1 maand geleden

Eindhoven, Nederland Salvia BioElectronics Voltijd

About us

Salvia BioElectronics is a medical device company pioneering neuromodulation therapies for migraine. Salvia's unique, paper-thin implant is designed to reduce the frequency and intensity of migraine attacks by delivering gentle electrical pulses to the nerves associated with the condition. The company is currently in the clinical stage of development. In addition, Salvia is considering potential opportunities the device creates for the treatment of cluster headache and other neurological disorders. Salvia has received the Breakthrough Device Designation from the United States Food and Drug Administration (FDA), which facilitates expedited market access for devices that treat life-threatening or irreversibly debilitating conditions.

The challenge

We offer a challenging position for a seasoned Regulatory Affairs Specialist. Reporting directly to Salvia’s Chief Medical Officer, you hold a key role as the regulatory expert in the cross-functional core-team responsible for the development and launch of our innovative medical device system. You consult with our international regulatory consultants to further refine Salvia’s global regulatory strategy. You liaise closely with R&D, clinical, market access, and quality to ensure compliance with regulatory and legal requirements for successful market authorization in the EU, USA, and other geographies. You are the primary contact with the Competent Authorities, Notified Body, EU expert panel, and FDA and you take ownership of writing and following up on FDA (Pre)Submissions, CE-mark dossiers, and other regulatory submissions.

Responsibilities

Develop and implement the regulatory strategy to obtain necessary approvals from regulatory agencies such as the FDA and CE-marking and ensure ongoing compliance throughout the product lifecycle. Primary contact person for regulatory submissions, reporting, and follow-ups, to the Competent Authorities, FDA, Notified Body, and other regulatory bodies. Coordinate, prepare, and submit regulatory submission documents. Provide regulatory guidance and support for post-market surveillance activities, including adverse event reporting and product complaints. Keeping abreast of regulatory changes and standards that may impact Salvia’s products.

Your Profile

You have an academic background in a relevant discipline, e.g. science, medicine, or pharmacy, and a clear interest in (medical) technology. You have recent and demonstrable (5+ years) experience in a medical device regulatory affairs role. Prior experience with active implantable medical devices is highly preferred. You have first-hand experience in obtaining regulatory approvals for medium-risk or high-risk medical devices in the EU and/or USA. You have an analytical mindset and excellent writing skills. You are a well-structured self-starter. 

Contact

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