RA manager - Medical Device

Syqe Medical is a dynamic company specializing in the design, development, and manufacturing of innovative medical devices for the inhalation of plant substances. We are seeking a highly skilled Regulatory Affairs Specialist with proven experience in the medical devices industry to join our team and contribute to the company’s regulatory efforts for the registration of our combination drug-device product with the FDA and globally.

Role Description:

As an RA Manager - Medical Devices at Syqe Medical, you will play a pivotal role in ensuring the successful regulatory approval and compliance of our combination drug-device product. Your responsibilities will encompass strategic planning, collaborative engagement, and meticulous oversight to ensure all regulatory standards are met. You will act as a senior resource for key aspects such as FDA submissions, Design Control, and Product Lifecycle, bringing your high experience to guide decision-making and expedite approvals.

Your expertise in medical devices and design control will be leveraged as you navigate the complexities of regulatory pathways, working closely with cross-functional teams to align strategies with business goals. Your strong command of regulatory writing will be crucial in creating coherent and compelling submissions. Overall, you will contribute significantly to the advancement of our innovative medical solutions, playing a vital role in improving patient lives through effective and compliant medical products.

Responsibilities:

• Report directly to the VP of Regulatory Affairs & QA: Establish and maintain direct communication channels with the Vice President of Regulatory Affairs & Quality Assurance.
• Active participation in the preparation and update of a regulatory strategy: Collaborate in the development and refinement of regulatory strategies specifically tailored for the combination drug device, aimed at securing FDA approval.
• Lead role in the compilation and submission of 510K applications (De Novo pathway): Take a proactive lead in assembling and submitting 510K applications through the De Novo pathway to the FDA.
• Lead RA proxy for Design Control activities: Serve as the Regulatory Affairs representative in R&D and Product groups, guiding and managing Design Control activities, including the creation of Design History Files and oversight of Design Change Controls (dECO) throughout the product lifecycle until transfer to production.
• Oversee regulatory writing for submissions: Supervise and contribute to the development of regulatory documents essential for submissions, ensuring accuracy and compliance.
• Team participation in medical device registration meetings: Actively engage as a team member in meetings related to medical device registrations, fostering collaboration with internal and external stakeholders.
• Ensure coherence, comprehensiveness, and adherence to standards: Guarantee consistency, comprehensiveness, and adherence to regulatory standards for all submissions.
• Stay updated with regulatory changes: Keep up-to-date of changes in regulatory legislation and guidelines, ensuring continuous compliance with evolving requirements.
• Oversee and supervise vigilance activities: Provide oversight and supervision for vigilance activities, ensuring proper documentation and adherence to regulatory requirements.
• Define requirements for labeling and packaging: Establish and communicate regulatory requirements for labeling and packaging in alignment with regulatory standards.
  
  

• Possess a minimum of 6 years of experience in the regulatory affairs department of medical devices companies (excluding startups). A great plus for previous experience in drug-device or biological-device combination products.
• Demonstrated expertise in 510k submissions. A great plus for experience with 510K Denovo submissions - a must
• Excellent knowledge in Design Control of medical devices per 21CFR 820 part 30 - a must
• Experience with embedded firmware (SW) Medical Devices – a high bonus,
• High and proven know-how in regulatory submissions to EU Notified Bodies per the new MDR,
• Previous experience with Human Factors per FDA regulations – preferred,
• Previous knowledge of regulatory requirements or actual regulatory submissions (benefit) to the competent authorities of the UK, Australia, and Canada.
• Hold an MS Degree in Bioengineering, a plus.
• Possess excellent regulatory writing skills in English.
• Exhibit exceptional teamwork abilities and effective communication skills in both Hebrew and English.