Job Number: 20019429

Location: Statewide - Nebraska, NE

Date Posted: 8-2-2017

Job Title: Principal Specialist, Regulatory Affairs

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What Reg Affairs Manufacturing FDA contributes to Cardinal Health

Regulatory Affairs Manufacturing (FDA) is responsible for planning, coordinating and implementing regulatory strategies for products that require government approval. Provides advanced administrative and technical services in support of the Health Physics Services under Cardinal Health Medical & Health Physics.

Location: Omaha, NE

Title: Principal Specialist, Regulatory Affairs (Health Physics Specialist)

Accountabilities

Essential functions of the job are denoted by an asterisk (*). Other duties may also be assigned. Please note that the essential functions may vary depending on department size and/or geographic location. Reasonable accommodations may be made to allow differently able-bodied individuals to perform the essential functions of the job.

*1. The candidate will be required to complete Health Physics instrumentation tests, including routine monitoring and special surveys, for conformance to established agreement state and NRC regulatory requirements.

*2. The individual will regularly reviews license commitments and ensures compliance.

*3. The candidate will be required to complete quarterly radiation safety audits for area client and ALARA (As Low As Reasonably Achievable) reviews as required.

*4 Tests, calibrates, and repairs measuring and indicating instruments for conformance to established regulatory agency requirements and Corporate standards; arranges for repair by manufacturer, as appropriate.

*5. Conducts group and individual training sessions; documents training activities as required.

*6. Be familiar with the DOT regulations for shipping and receiving of radioactive materials.

*7. The individual must be able to respond to and identify problem areas by developing new procedures in support of radiation safety, for area clients.

8. The candidate must be familiar with the personnel monitoring devices and the regulated

personnel dose limits.

9. This candidate will be trained to prepare R.A.M. licenses and R.A.M. license amendments.

10. Provides customer survey meter calibration and other radiation safety services as required by the client’s RAM License.

11. Have the ability to contacts new customers and markets the health physics program, thereby expanding Cardinal’s customer base.

12. Prepare and conduct lectures on radiation safety for area clients.

13. Performs other job-related duties as requested and works effectively with other team members to ensure the goals and objectives of the department are met.

Qualifications

  • Bachelors in related field, or equivalent work experience, preferred
  • 2-5+ years experience in related field, preferred
  • Minimum A.A. degree and certification in Nuclear Medicine Technology. A-B.S. degree is preferred. Or a B.S. degree in physics or other related sciences.
  • At least two years related work experience; some supervision and training experience preferred.
  • Advanced knowledge of fundamental concepts, practices and procedures of health physics

WORK ENVIRONMENT: In general, the following conditions of the work environment are representative of those that an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to allow differently able-bodied individuals to perform the essential functions of the job within the environment. Travel will be required.

The primary work environment is the Cardinal nuclear pharmacy, which is a clean, orderly, properly lighted and ventilated facility or in the Field. Employees are exposed to very low doses of radiation from radiopharmaceuticals suitable for human use. The lab is operated under well-controlled and closely monitored conditions that are highly regulated by State and Federal agencies and internal quality and regulatory guidelines and is monitored for exposure. Noise levels are considered low to moderate. Cardinal employees work with and around other employees.

Outside of the Cardinal NPS pharmacy, the Health Physics Specialist may be working in the community at large. Driving to medical facilities within the region is required. The outside work environment is characterized by traffic, noise, and at times, inclement weather conditions. Shift work may be applicable.

PHYSICAL DEMANDS: In general, the following physical demands 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 allow differently able-bodied individuals to perform the essential functions of the job.

Hand and finger dexterity; sitting, walking, standing, stooping, bending, climbing ladders, close vision, general hearing, clear speech, ability to lift up to 50 lbs.

What is expected of you and others at this level

  • Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
  • May contribute to the development of policies and procedures
  • Works on complex projects of large scope
  • Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives
  • Completes work independently receives general guidance on new projects
  • Work reviewed for purpose of meeting objectives
  • May act as a mentor to less experienced colleagues

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.


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