http://biotech.fyicenter.
Guest
|
 Posted: Tue Jul 29, 2008 4:19 pm Post subject: US-: Regulatory Associate in biotech |
 |
|
US-: Regulatory Associate in biotech
To apply for this position, please visit this Website.
http://biotech.fyicenter.com/jobs/99894495_Regulatory_Associate_in_biotech.html
To see other BioTech job opportunities, please visit http://biotech.fyicenter.com/
Date: 29-Jul-2008
Regulatory Associate in biotech
SUMMARY:
The Regulatory Associate has responsibility for preparing and
submitting domestic and international regulatory submissions. He/she
is also responsible for writing modification documentation and
reviewing labeling to ensure compliance with regulatory requirements.
Amount of independence provided dependent on experience and
demonstrated work product. PRINCIPAL DUTIES:
* Prepare and submit 510(k)s and letters-to-file * Prepare technical
files and design dossiers for class IIa and class III products *
Prepare and submit applications for foreign (non-EU) device
registration * Review labeling and advertising to ensure compliance
with FDA requirements * Provide regulatory guidance and support to
project core teams * Participate in development of regulatory
strategies
REQUIREMENTS:
Experience: 2 years minimum of documented success in regulatory
affairs for a medical device company. Experience with catheter based
products highly desired. Experience with 510(k) and IDE submissions
required. Experience with PMA submissions highly desired. Thorough
understanding of FDA and international regulations required.
Education: A minimum of a BS degree in a scientific discipline such as
engineering, physics, chemistry, biology or biochemistry.
Special Skills/Abilities: Attention to detail and accuracy, excellent
oral and written communication skills, demonstrated proficiency to
respond effectively to meet management objectives, self-motivated, and
possess professional ethics, excellent planning and organizational
skills, strong interpersonal /group skills, capable of working
collaboratively with colleagues in all functions, ability to
understand and comply with domestic and international regulatory
requirements.
Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/ |
|
