Medasense Biometrics is seeking for a Regulatory Affairs Specialist
Medasense Biometrics is a medical device/digital health company in the field of pain. Medasense’s goal is to enable personalized pain management for patients suffering from acute and chronic pain. Medasense has developed a proprietary platform technology that enables clinician’s to objectively assess changes in a patient’s pain by monitoring the changes in physiological parameters affected by pain and by analgesic medications. This technology enables clinicians to improve treatment and personalize the patient’s pain management which helps minimize adverse events, improve clinical outcomes and reduce costs.
The Regulatory Affairs Specialist is responsible and accountable for developing and executing sound strategies for regulatory submissions and registrations for complex new product development projects. This position interfaces with multiple projects and branches within the company, provides instruction, guidance, and regulatory interpretations to achieve rapid worldwide clearance/approval/registrations of Medasense products.
Duties and Responsibilities:
- Develops and execute regulatory strategies for moderately to highly complex submissions to FDA and other regulatory agencies. Will prepare or assist in the preparation of Pre-IDE, De Novo Petition, and 510(k) submissions.
- Provides risk assessments of strategies and regulatory options to various company branches. Exercises considerable latitude in determining how to most efficiently organize activities to complete these submissions.
- Prepares or provides input into Technical Files for CE marking, and interfaces as needed with Notified Bodies regarding significant changes to products.
- Prepares or provides input into other strategic markets such as Latin America, Korea, Japan, Chine, etc.
- Remains current on regulatory issues/trends affecting business unit products, assessing and communicating their impact to others in the business.
- Suggests significant opportunities for improvement (cost, cycle time, quality, etc.). Analyzes feasibility and participates in developing, executing, or monitoring implementation plan.
- Independently manages and monitors multiple complex, novel, and/or diverse projects simultaneously, including projects that involve several functional areas without direct supervision.
- Support post market activities, including vigilance, complaint handling, PMS, notification of change, etc.
Working hours: Full time job. Office location is in Ramat Gan.
Reports to: Regulatory Affairs Manager
Interface with: R&D, QA, Clinical, Marketing, Sales and Operations
- Bachelor/Master of Science degree in a software, technical, or biomedical discipline;
- Minimum 3 years of directly related regulatory experience in the medical device area.
- Demonstrated experience in interpreting subjective and complex aspects of specific regulations and has thorough understanding of multiple sets of associated regulations.
- Demonstrates in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes. May be recognized internally as technical or subject matter expert in multiple areas.
Please submit your resume to: firstname.lastname@example.org