Regulatory Job 558617 - Sr. RA Leader

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558617 - Sr. RA Leader UT 75 - 100k (J#13304)
Education: Bachelors Degree
Experience: 1 - 3 years

Essential Functions (Responsibilities):
Lead the development and maintenance of Product Approval/Clearance/Licensing documentation and notifications, as required by Regulatory Agencies. This documentation includes, but is not limited to:
- FDA PMAs or 510ks
- Notified Body Technical Files and updated notifications
- Health Canadian License Applications and updated notifications

Lead RA efforts as member of cross-functional teams in support of Engineering, Service and Manufacturing projects, to ensure regulatory activities are completed (e.g., labeling reviews, 510k decision tree, etc.).
Ensure regulatory compliance and optimization of Regulatory procedures through:
- Development, maintenance and improvement of documented processes, training, & metrics

Lead key RA activities, as assigned. May include, but are not limited to activities in the following areas:
- X-Ray Officer
- Radiation Safety Officer
- Training
- Internal Auditing
- Regulatory Site Registrations, Product Listing and Product Licensing
- Annual Regulatory Fees coordination and reporting
- Country Regulatory Files, Product Regulatory Trackers
- Supervisory or Mentoring Role to RA Leader positions

Radiation health representative to interface with FDA CDRH (X-ray radiation and laser), physicists in health care facilities, international rad health requirements, engineering teams and manufacturing testing and certification of radiation devices:
- Primary CDRH contact
- Prepare & submission of CDRH reports
- Assist FDA notifications & FMI activities
- Specify rad health and laser requirements for SDRS. (i.e. 21 CFR Subchapter J, IEC 60601-1-3, 60601-2-7, 60601-2-28, 60825, etc.)
- Specify test methods, Assist 3rd party, risk management for rad health risks, mitigations.
- Specify mfg test requirements for rad heath certification. (i.e. leakage radiation, EER, primary barrier, AL equiv., beam quality, alignment, DAP, validation, etc.)

Qualifications/Requirements:
* Bachelor's Degree.
* minimum of 3 years of employment in the RA field.
* minimum of 3 years experience in a medical device or pharmaceutical industry.
* minimum of 3 years experience with regulatory submissions.
* minimum of 3 years experience with labeling reviews.
* Ability to communicate effectively (both written and oral) in English.

* You must be willing to take a drug test.
* You must be willing to submit to a background investigation, including for example, verification of your past employment, criminal history, and educational background.
* You must be legally authorized to work in the United States without work sponsorship at the time of hire.
* You must submit your resume through gecareers.com or a job board to be considered for a specific job opening (internal candidates should apply through COS).
* To the extent you are applying for a position that may require you to operate a GE owned/leased, privately owned/leased or rental vehicle for company business, you must be willing to submit to a check of your driving record.

Desired:
* Experience as X-Ray Officer.
* Experience as Radiation Safety Officer.
* Ability to work independently in fast-paced environment with little supervision.
* Ability to adapt to constant change.
* Team-oriented and responsive to customer needs.
* Strong Leadership skills.
* Quality-Focused, Attentive to Detail and Results-Oriented.
* Strong computer skills using Microsoft Windows/Office environment.
* Experience interfacing with External Regulatory Agency (e.g., FDA).
* Experience conducting internal audits.
* Experience with software devices.
* Experience with training and course development.
* Experience working closely with other functional areas (e.g., Engineering, Manufacturing, Service) to ensure compliance to applicable regulations in the areas of Design, Service and Manufacturing.
* Experience researching rad health requirements for international sale (i.e. US FDA CFRs, European Directives, Health Canada, China GBs, Japan JIS, etc.)
General:
GE Healthcare Interventional Cardiology Surgery (ICS) - Surgery provides transformational medical technologies that will help shape a new age of patient care. GEHC Surgery is dedicated to detecting diseases earlier and tailoring treatment for individual patients. In particular, GEHC-Surgery offers a full range of mobile fluoroscopic imaging systems for minimally invasive surgery, a fixed room imaging system for urology as well as navigation and 3D visualization instrumentation. Products range from a specialized mini C-arm for extremity imaging to cost-effective full-sized C-arms for general surgery, orthopedic and gastrointestinal procedures, as well as advanced systems for use in pain management, vascular, neurovascular and cardiac procedures. Located in Salt Lake City, GEHC-Surgery has $500 million in revenue globally and growing.

GE Healthcare provides transformational medical technologies that are shaping a new age of patient care. GE Healthcare's expertise in medical imaging and information technologies, medical diagnostics, patient monitoring and life support systems, disease research, drug discovery, and biopharmaceutical manufacturing technologies is helping physicians detect disease earlier and to tail or personalized treatments for patients.

GE Healthcare offers a broad range of products and services that are improving productivity in healthcare and enhancing patient care by enabling healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases, and other conditions. GE Healthcare is a $15 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 43,000 people committed to serving healthcare professionals and their patients in more than 100 countries.

GE is an Equal Opportunity Employer.

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