[Hiring] Regulatory Affairs Specialist @MiniMed

Role Description

An individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

• Prepare, coordinate, and compile regulatory submission packages (e.g., registrations, renewals, design change submissions) to ensure timely approvals in Israel and potential other countries.
• Lead or support activities required for annual registrations and license renewals.
• Collaborate with regional post-market and quality teams to ensure compliant execution of vigilance requirements and post-market regulatory obligations.
• Lead and support activities required for Regulatory Clinical submissions.
• Review promotional materials, labelling, and product claims for regulatory accuracy and compliance.
• Engage directly with regulatory authorities on defined matters, supporting queries, data requests, and remediation activities.
• Recommend regulatory strategies to support the earliest possible approval.
• Monitor regulatory trends and support MiniMed readiness for evolving requirements in Israel.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Chemistry, or related technical field.
• 2-5 years of medical device regulatory experience (depending on level) tied to Israeli submissions and processes, with strong knowledge of Israeli regulation.
• Proficiency in Hebrew and English.
• Experience with Israeli registration processes, technical documentation preparation, interaction with Ministry of Health, as well as product release licensing procedures, post-market surveillance, Field Safety Corrective Actions (FSCA) support, while also possessing expertise in hosting or supporting regulatory audits.

Benefits

• MiniMed offers a competitive salary and flexible benefits package.
• A commitment to our employees lives at the core of our values: We recognize their contributions.
• Employees share in the success they help create.
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life.

Company Description

We want to make every day a better day for people living with diabetes. Our team of creative innovators around the globe share a passion for finding the simplest solutions to the problems that people with diabetes face on a daily basis. For more than 40 years, we've been redefining what's possible, from intelligent dosing systems designed for real life to predictive insights that stay a step ahead, and we're dedicated to continuing to support our customers through every step of their journey — meeting them where and how they need it. Role Description

An individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

• Prepare, coordinate, and compile regulatory submission packages (e.g., registrations, renewals, design change submissions) to ensure timely approvals in Israel and potential other countries.
• Lead or support activities required for annual registrations and license renewals.
• Collaborate with regional post-market and quality teams to ensure compliant execution of vigilance requirements and post-market regulatory obligations.
• Lead and support activities required for Regulatory Clinical submissions.
• Review promotional materials, labelling, and product claims for regulatory accuracy and compliance.
• Engage directly with regulatory authorities on defined matters, supporting queries, data requests, and remediation activities.
• Recommend regulatory strategies to support the earliest possible approval.
• Monitor regulatory trends and support MiniMed readiness for evolving requirements in Israel.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Chemistry, or related technical field.
• 2-5 years of medical device regulatory experience (depending on level) tied to Israeli submissions and processes, with strong knowledge of Israeli regulation.
• Proficiency in Hebrew and English.
• Experience with Israeli registration processes, technical documentation preparation, interaction with Ministry of Health, as well as product release licensing procedures, post-market surveillance, Field Safety Corrective Actions (FSCA) support, while also possessing expertise in hosting or supporting regulatory audits.

Benefits

• MiniMed offers a competitive salary and flexible benefits package.
• A commitment to our employees lives at the core of our values: We recognize their contributions.
• Employees share in the success they help create.
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life.

Company Description

We want to make every day a better day for people living with diabetes. Our team of creative innovators around the globe share a passion for finding the simplest solutions to the problems that people with diabetes face on a daily basis. For more than 40 years, we've been redefining what's possible, from intelligent dosing systems designed for real life to predictive insights that stay a step ahead, and we're dedicated to continuing to support our customers through every step of their journey — meeting them where and how they need it.