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1+ months

Regulatory Affairs Specialist

Medtronic
Jerusalem, OH 43747
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Regulatory Affairs Specialist

Location:

Jerusalem, Israel

Requisition #:

21000468

Post Date:

Feb 17, 2021


**Careers that Change Lives**


Were 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. Well support you with the training, mentorship, guidance, and networks you need to advance, and empower you to work in the way thats 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**


Actively contribute in the development of regulatory strategies for product development and approval, as well as product lifecycle maintenance. You will be able to support regulatory activities with different partners and their global strategy for product launch.

Performs coordination and preparation of document packages for US FDA regulatory submissions, EU MDD/MDR Technical Files, and international packages.

Assess product changes and their global regulatory impact.

Leads or compiles all materials required in submissions, license renewal and annual registrations for internal and external partners.

Provide customer support to global partners.

To interact with internal marketing, RD, QA, project managers as well as external Regulatory partners.

Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.

Monitors and improves tracking / control systems.

Keeps abreast of regulatory procedures and changes.


**Must Have:**


+ Bachelors degree in science with 2+ years of experience in regulatory affairs and/or QA medical device or pharma industry.

+ Excellent English skills (writing, reading and communicating)

+ Product development experience.

+ Ability to comprehend principles of engineering, physiology and medical device use.

+ Familiarity with regulatory submissions and requirements.

+ Previous customer-facing and/or project management experience is a plus.

+ Previous experience working with global team.

+ Comfortable working with international and multi-cultural department and groups.


**Nice to have:**


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

+ Working knowledge Standard, Guidances, and Regulations.

+ Familiarity with regulatory requirements in major markets as US and EU, as well as international markets.

+ Ability to effectively manage multiple projects and priorities.

+ Experience with regulatory submissions.

+ Project management skills.

+ RAPS certification (RAC).


**About Medtronic**


Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.


**PHYSICAL REQUIREMENTS**

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers.

At Medtronic, you will find a diverse team of innovators who bring their unique backgrounds and their individual life experiences to work every day. We work hard to cultivate a workforce that reflects our patients and partners, we believe its the only way to drive healthcare forward. We want to attract a diverse workforce, regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, veteran status, or any other characteristic protected by state or local law. Join us, and bring the power of your point of view to our culture of collaboration and innovation. It is through strong diversity, inclusion and engagement that we can remain a leader in medical technology and solutions. And by embracing everything you have to offer your unique perspectives, talents and contributions we can live up to the promise of our Mission.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

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Posted: 2021-02-19 Expires: 2021-04-30
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Regulatory Affairs Specialist

Medtronic
Jerusalem, OH 43747

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