Regulatory Affairs Specialist – Aortic Business Unit
REGULATORY AFFAIRS SPECIALIST – Aortic Business Unit
The Aortic Business unit is a part of the Aortic, Peripheral and Venous (APV) Business Unit which specializes in life saving technologies to treat the diseases of the Aorta such as Aneurysms, Aortic dissections and transections. This position will reside in the Aortic organization and support our life saving Aortic stent graft therapies.
Careers That Change Lives
The Regulatory Affairs Specialist will provide worldwide regulatory affairs support for aortic products. The Regulatory Affairs Specialist is responsible for developing global regulatory strategies for commercialization of aortic products (Class II & III), maintaining existing products, providing advice on regulatory requirements, preparing worldwide submissions and performing global regulatory assessments of changes to the products.
A Day In The Life:
- Provide regulatory support to currently marketed products.
- Assess product design, manufacturing, packaging, sterilization, and labeling changes for compliance with applicable regulations and prepare submissions, as required, by geography.
- Prepare required submissions and reports for FDA and other global regulatory bodies.
- Work closely with cross functional team members in quality, clinical and R&D as required on pre-market and post-market projects to write submissions as well as resolve regulatory agency questions.
- Support global regulatory submissions such as IDEs, PMA submissions and supplements for US, EU Technical Documentation, Japan Shonin and other worldwide regulatory applications.
- Assist in interacting with reviewers from regulatory agencies on specific projects.
- Provide support during internal and external audits
- Keeps abreast of worldwide regulatory requirements.
Must Have: Minimum Requirements
- Bachelor’s degree and minimum 2 years of experience in medical device regulatory affairs
- OR an advanced degree with no prior experience
Nice To Have
- Experience working with medical device or pharmaceutical regulatory submissions
- Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).
- Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills.
- Ability to effectively manage multiple projects and priorities.
- Experience with Class II/III medical devices (510(k), PMA, IDE)
- Experience with FDA and international regulatory agency requirements
- Project management skills
- Effective interpersonal skills
- Effective team member
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. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job 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. For Office Roles: 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. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
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Job posted: 2020-11-18