A new Job, ID: 182268 <http://www.ejobsville.com/display-job/182268> was
added at eJobsVille.com - For the Best Tech Jobs in Town
<http://www.ejobsville.com>

Title:  Regulatory Affairs Specialist  posted on 2014-06-03 15:20:15

Job Description:
*Title :               Regulatory Affairs  SpecialistLocation:*
*Waukesha, WisconsinDuration:         Full Time*




Job Requirements: *Required :*

1. Bachelor’s Degree (or international equivalent) in a related field such
as: Regulatory Science, Biomedical Engineering, Biology, Chemistry, English
(with a technical writing emphasis), Legal Studies, Law, Nursing, Physician
Assistance, Pharmaceutical Science, Pharmacy OR *minimum of 4 years
progressive regulatory affairs experience in medical device or
pharmaceutical industry or medical product regulation agencies, including
knowledge and experience applying drug or device laws and regulations*
2. Strong analytical skills
3. Ability to work in a team environment with minimal supervision on
projects and activities
4. Ability to prioritize, plan & evaluate deliverables
5. Knowledge & experience conducting scientific, regulatory, legal, or
business research.
6. Excellent verbal and written communication and presentation skills with
the ability to communicate in English in an easy to understand manner
7. Experience using spreadsheet and presentation software
8. Must be willing to travel up to 5% of the time

*Preferred :*
1. Advanced degree in scientific, technology or legal disciplines.
2. Regulatory Affairs Certification (RAPS).
3. Experience in a medical device or pharmaceutical industry.
4. Knowledge of Quality Management Systems (QMS).
5. Experience working across cultures/countries/sites.
6. Demonstrated experience interfacing with regulatory agencies (e.g. FDA,
MHLW, Health
Canada, KFDA, etc.) and standards bodies such as AAMI, IEC, ISO, UL.
7. Demonstrated experience prioritizing conflicting demands from multiple
business entities in
an extremely fast paced environment.
8. Demonstrated understanding of healthcare environment and knowledge of
current
competitive, commercial or political situations and their impact on GEHC
regulatory
strategies.



Salary: DOE


*Click here to view full job description and apply
<http://www.ejobsville.com/display-job/182268>  (Registration not mandatory
to apply for this job)*

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