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
Current Available & Projected Jobs
Regulatory Affairs Specialists
Top Expected Tasks
Regulatory Affairs Specialists
01
Coordinate efforts associated with the preparation of regulatory documents or submissions.
02
Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
03
Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
04
Coordinate, prepare, or review regulatory submissions for domestic or international projects.
05
Prepare or maintain technical files as necessary to obtain and sustain product approval.
06
Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
07
Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
08
Coordinate recall or market withdrawal activities as necessary.
09
Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
10
Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
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
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Regulatory Affairs Specialist - Post Market
Canon USA & Affiliates Phoenix, AZ 85067Posted 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 TypeFull Time
Related Careers & Companies
Health Sciences
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