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Health Sciences

Regulatory Affairs Specialists

Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.

Salary Breakdown

Regulatory Affairs Specialists

Average

$67,680

ANNUAL

$32.54

HOURLY

Entry Level

$38,170

ANNUAL

$18.35

HOURLY

Mid Level

$62,470

ANNUAL

$30.04

HOURLY

Expert Level

$101,760

ANNUAL

$48.92

HOURLY


Supporting Programs

Regulatory Affairs Specialists

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  Chandler, AZ 85225-2479      Degree Program

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  Phoenix, AZ 85034      Degree Program

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  Phoenix, AZ 85032-1200      Degree Program

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  Tempe, AZ 85281-6950      Degree Program

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  Scottsdale, AZ 85256-2626      Degree Program

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  Mesa, AZ 85202-4866      Degree Program

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  Phoenix, AZ 85034      Degree Program

GateWay Community College
  Phoenix, AZ 85034      Certification

Current Available & Projected Jobs

Regulatory Affairs Specialists

1

Current Available Jobs

12,120

Projected job openings through 2032


Top Expected Tasks

Regulatory Affairs Specialists


Knowledge, Skills & Abilities

Regulatory Affairs Specialists

Common knowledge, skills & abilities needed to get a foot in the door.

KNOWLEDGE

English Language

KNOWLEDGE

Law and Government

KNOWLEDGE

Biology

KNOWLEDGE

Computers and Electronics

KNOWLEDGE

Administration and Management

SKILL

Active Listening

SKILL

Speaking

SKILL

Writing

SKILL

Critical Thinking

SKILL

Judgment and Decision Making

ABILITY

Written Comprehension

ABILITY

Written Expression

ABILITY

Oral Comprehension

ABILITY

Oral Expression

ABILITY

Deductive Reasoning


Job Opportunities

Regulatory Affairs Specialists

  • Regulatory Affairs Specialist - Post Market
    Canon USA & Affiliates    Phoenix, AZ 85067
     Posted 17 days    

    **Regulatory Affairs Specialist - Post Market - req1434**

    **OVERVIEW**

    Reporting to the Director Regulatory Affairs, the Regulatory Affairs Specialist is responsible for complaint handling, coordination of product recalls, FMI processes, processing electronic submissions and state registrations.

    **RESPONSIBILITIES**

    + Remote position, **west coast hours mandatory**

    + Coordinate the complaint handling process to include processing of reportable events

    + Provide information as requested for the filing of FDA recalls

    + Coordinate FMI process, including monitoring and reporting status and completion

    + Process electronic submissions (e.g. 3500A, 2579, Product Reports, Annual Reports)

    + Coordinate state registrations, including monitoring regulations and preparing and submitting documentation to each state as required

    + As requested, write/review CMSU policies, procedures and guidance documents incorporating regulatory requirements/actions

    + Assist in maintaining proper preparedness for State or Federal (FDA) authorities

    + Represent interests of RA in cross functional teams as needed

    \#LI-Remote

    \#LI-NA1

    **QUALIFICATIONS**

    + Excellent interpersonal, communication, and organizational skills

    + Ability to develop and maintain effective working relationships internally and externally

    + Good PC skills, including MS Word, Excel, Oracle, Sales Force, etc.

    + 2 Years Regulatory Affairs experience in medical device industry required

    + Minimum Education Level: 2 Year / Associate's Degree

    + 4 Year/ Bachelor's Degree (STEM) preferred

    + Pay Information: Min. salary of $72,000 to max $116,100 (annual equivalency)

    **_About us!_**

    _Canon Medical Systems USA, Inc., a world leader in diagnostic imaging, is in search of qualified candidates to fill our open positions. Canon Medical Systems offers a competitive salary and benefits package, we support a diverse workplace and are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, sexual orientation, gender identity, religion, national origin, protected veteran status, or on the basis of disability. We invite you to join and become part of our Canon family._


    Employment Type

    Full Time


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