#Regulatory Affairs Lead - ISR
Who are we?
We are here to improve the lives of patients through innovative technologies. We're a rapidly growing inter-disciplinary team of professionals passionate about developing disruptive technologies that empower physicians to make better treatment decisions. We are addressing one of today’s most critical global health concerns – the rise of antibiotics resistant bacteria (www.me-med.com).
Who are we looking for?
If you are a talented Regulatory Affairs expert, with exceptional make things happen approach, a drive for excellence and with the experience of leading and executing regulatory strategy, then we need to talk!
We are seeking an A+ Regulatory Affairs Lead, to join us in an exciting period of growth and acceleration to lead one of the most critical factors to our success – driving efficient and timely regulatory clearance!
You will lead oversight of Regulatory Affairs related matters with responsibility for developing and executing regulatory strategy, and ensuring efficient regulatory processes to fulfil our business objectives and support our growth!
This is your chance to make an impact on patients' lives and take an important part in driving MeMed success.
What will you do?
- Lead communication with regulatory authorities, such as FDA and Notified Body
- Work with cross-functional program teams to ensure compliance with regulations, and develop regulatory strategies and plans
- Lead CE Marking process to comply with the EU IVDR
- Lead product’s CE certification audits by Notified Body, and support quality system audits (ISO9001/ISO13485)
- Lead preparations of Pre-Submissions / 510(k) Submissions to FDA
- Support Information Security Management System activities
- Mentor, train and lead oversight of RA related matters
- BSc or a higher degree in the area of Biotechnology / Biology / Biochemistry
- At least 5 years of experience in developing and executing regulatory strategy in a fast-paced environment in a Biotech/Pharma company
- Experience in IVD – an advantage
- Experience in communication with FDA, and preparation of 510(k) submissions
- Vast experience with audits of regulatory bodies, and with CE Marking process
- Exceptional analytical and technical skills, and excellent English (Verbal and Written)
- Accountability to make things happen and drive for excellent execution
- Exceptional project management skills, attention to detail, ability to collaborate and get things done in a fast-paced environment
- Creative and independent problem-solving skills with high professional maturity
- Outstanding communication skills
Location & Travel:
MeMed headquarters are based in Haifa, Israel. Some travel will be required.