Regulatory Affairs Specialist

לחברת הזנק מבטיחה, קטנה ודינמית בתחום המכשור הרפואי, דרוש\ה מנהל\ת רגולציה מוכשר\ת, מנוסה ופרקטי\ת עם יכולות עבודה עצמאיות, להובלה של רגולציה למכשיר רפואי מולטי דיסציפלינרי פורץ דרך בדרכו לשוק

החברה שייכת לקבוצה מנוסה וותיקה בתחום המכשור הרפואי עם חברות נוספות בתחום, תפקיד מעניין עם אופק רחב להתפתחות עתידית מעניינת

דיווח ישיר למנכ"ל

עבודה בסביבה דינמית ומאתגרת, אך אנושית, גמישה, נעימה ומתגמלת

מיקום המשרדים בפארק התעשייה קיסריה. שילוב נוח עם עבודה מהבית

לעונים על הדרישות מומלץ להתקשר

ספי - 0545789080

המשרה מיועדת לגברים ולנשים כאחד

Responsibilities

1. Define and oversee the regulatory strategy of the company, ensuring alignment with business objectives.
2. Manage and execute FDA pre-submissions and FDA submissions, as well as CE marking as needed.
3. Conduct regulatory gap analysis, risk assessments, and provide recommendations.
4. Coordinate, prepare, and execute document packages, including 510(k) pre-market notifications, technical files, and other required submissions.
5. Collaborate closely with R&D and Clinical teams to determine and execute regulatory submissions, strategies, trials, test plans, V&V plan and clinical trials, ensuring regulatory compliance throughout the process and integrating regulatory needs into the development lifecycle.
6. Ensure compliance of product labelling, instructions, and marketing materials with FDA requirements and oversee post-market surveillance.
7. Provide training and guidance to internal teams on regulatory requirements and best practices.
8. Serve as the company’s Regulatory Affairs representative in meetings, including pre-submissions, FDA consultations, and with regulatory consultants.
9. Prepare for and represent the company during regulatory audits and inspections.
10. Report directly to the CEO.
11. Collaborate with global team members and stakeholders to ensure effective execution of regulatory strategies.

Qualifications

1. Bachelor’s degree in a scientific discipline (e.g., engineering or life sciences).
2. Previous experience with FDA submissions, pre-submissions, audits, or similar regulatory processes.
3. 8+ years of proven experience in regulatory affairs within the medical device industry.
4. Experience with a multidisciplinary medical device integrating Hardware and Software.
5. Strong attention to details and practical and balanced problem-solving abilities.
6. Ability to work effectively with a multi-disciplinary team, as well as external partners and vendors.
7. Ability to independently lead processes and tasks.
8. Knowledge and experience in utilizing research and conducting statistical analysis.
9. Strong technical skills: proficient in Microsoft Office Suite (Excel, Word, PowerPoint).
10. Excellent oral and written communication and presentation skills in both English and Hebrew.
11. Proven leadership ability, with experience mentoring junior regulatory team members.
12. Experience working cross-culturally and with diverse teams.