Sr. Regulatory Affairs Specialist BARRX Medical
THIS JOB HAS EXPIRED Job Description
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Build and maintain a working familiarity and practical understanding of the regulatory requirements of domestic and international agencies, as required.
Prepare marketing applications for approval of high risk medical devices worldwide.
Interface with consultants and regulatory agencies during the preparation and approval phases of submissions.
Support internal groups for regulatory reviews or assessments.
Prepare supplements and amendments based on regulatory assessments and product modifications.
Prepare, support and submit periodic agency required reports (Annual Reports, Investigator Listings, Post Approval Study findings, etc)
Take part in and support core team meetings.
Provide guidance regarding regulatory requirements, as requested
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
Review industry newsletters and regulatory journals in order to monitor registration requirements.
Attend product registration conferences and seminars.
Broad Knowledge of biology, chemistry or related field.
Excellent verbal and written communication, as well as organizational skills.
Proficient with MS Word, Excel, Power Point. Self-motivated; can work independently with minimal supervision.
Demonstrated experience with submission to the European Union.
Demonstrated experience in preparing 510(k) submissions for FDA.
RAC a plus.
Bachelors Degree in scientific discipline,
Masters Degree and RAC credential preferred
EXPERIENCE (please note required or Preferred):
Minimum of 3- 5 years experience in Regulatory Affairs arena required
WORKING ENVIRONMENT/PHYSICAL ACTIVITIES:
Usual office environment with frequent- sitting, walking, standing, kneeling, crouching, crawling, balancing, stooping and occasional- climbing.
Frequent- use of eye, hand and finger coordination enabling use of office machinery.
Oral and auditory capacity enabling interpersonal communication as well as communication through automated devices such as the telephone.
Light physical effort required by handling objects up to 20 pounds occasionally- and/or up to 10 pounds frequently.
-Occasional: Activity exists less than 1/3 of the time.
-Frequent: Activity exists between 1/3 and 2/3 of the time.
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
||540 Oakmead Parkway |
Sunnyvale, CA 94085
THIS JOB HAS EXPIRED