Regulatory Affairs Specialist

תיאור התפקיד

Careers that Change Lives

We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide.

Come strengthen your specialized skills and enhance your expertise. We’ll support you with the training, mentorship, guidance, and networks you need to advance, and empower you to work in the way that’s best for you.

Together, we can confront the challenges that will change the face of healthcare. Join us for a career that change lives.

A Day in the Life

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

You will provide global regulatory strategy for new products and product changes.

You will direct or perform coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits, and inspections.

You will lead or compiles all materials required in submissions, license renewal and annual registrations.

You will recommend changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.

You will monitor and improve tracking / control systems.

You will keep abreast of regulatory procedures and changes.

You may direct interaction with regulatory agencies on defined matters.

You will support Regulatory Authorities/ Notified body audits.

Must Have:

Education:

Bachelor’s degree with 2+ years of experience in regulatory affairs and/or medical device industry 

דרישות התפקיד

Experience:

Working knowledge of IEC 60601-series standards

Familiarity with regulatory requirements in major international markets

Experience with EU- MDR

Experience with 510(k)/IDE/PMA device product submissions and other worldwide submissions and clearances.

Experience performing advertising and promotion reviews for medical devices.

Experience with FDA and international regulatory agency requirements

Nice to have

Project management skills.

Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).

Product experience with Radio Equipment Directive (RE-D)

Prior experience with software-driven devices.

Experience with working with principles of engineering, physiology and medical device use.

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