Regulatory Affairs Post-Market Specialist

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life
The Regulatory Affairs Post-Market Specialist leads and executes key post-market activities to ensure compliance with the Israeli Ministry of Health (AMAR) and Medtronic's requirements. This includes managing adverse event (vigilance) reporting, coordinating Field Safety Corrective Actions (FSCAs), and serving as a regulatory contact for post-market issues in Israel. The role involves close collaboration with cross-functional and global teams to maintain the highest standards of quality and patient safety.

Responsibilities may include the following and other duties may be assigned:

Lead the execution and follow-up of Field Safety Corrective Actions (FSCAs) including coordination with internal teams, customers, and submission to the Ministry of Health (MOH)
Manage the adverse event (vigilance) reporting process to the Israeli MOH, ensuring timely and accurate submissions in accordance with local regulatory timelines and guidelines
Collaborate closely with internal stakeholders including global post market teams to ensure consistent and compliant execution of post-market activities
Serve as a regulatory contact for the Israeli MOH on all post-market issues, including adverse events, recalls, field actions, and periodic updates
Stay up to date with changes in AMAR regulations, MOH guidelines, and industry standards, and communicate potential impacts to management and relevant teams
Participate in the local recall committee or crisis response team in the event of product safety issues requiring urgent action
Provide training to local teams on vigilance reporting, complaint handling, and FSCA procedures to ensure consistent and compliant practices

Required Knowledge and Experience:

Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or a related technical field; advanced degree or relevant certification in Regulatory Affairs is a plus
Minimum of 3 years of experience in Regulatory Affairs, preferably in post-market surveillance or related compliance activities. Experience in the medical device industry is an advantage
Excellent project management and communication skills, with a demonstrated ability to collaborate cross-functionally and engage with global regulatory teams
Detail-oriented and organized, capable of managing multiple priorities while meeting strict regulatory deadlines
Fluency in Hebrew and English, both written and verbal, is essential
Experience in post-market activities related to Medical Devices including adverse event reporting, Field Safety Corrective Actions (FSCAs), complaint handling and recall processes is an advantage

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.