Previous Job
Previous
Regulatory Affairs
Ref No.: 18-05355
Location: Franklin Lakes, New Jersey
Work Authorization:US Citizen
Segment:Commercial
JOB OPENING TYPE:SONJ- New Request
JPAS:NO
  • Period
    05/29/2018 to 09/30/2018
Work Location:
1 Becton Drive
Franklin Lakes
New Jersey
USA
7417

Description:
Provides routine administrative support to the MDS Regulatory Affairs Team. This position is able to use good judgment in order to complete all tasks in a timely manner with attention to detail and accuracy. Able to act independently and evaluate unusual situations as necessary. Maintain confidentiality in all matters. Able to maintain a high level of organizational and administrative skills along with good communication and interpersonal skills.


RESPONSIBILITIES:
1. Coordinate and administer the Regulatory Change Management program (ACR). Evaluate each request to ensure appropriate for department, compile all requested information, and compile summaries of International responses to ACR, and file RA "strategies” and ACR responses appropriately.
2. Ensure the records are organized and updated in a timely manner.
3. Collect information from the international regulatory team and follow up to ensure completion of the ACR as needed.
4. Coordinate and collect specific registration information with R&D, Manufacturing, QA, Medical and other applicable departments, as necessary to support registrations or other regulatory projects.
5. Interface with OEMs to collect specific registration information.
6. Responsible for ordering department supplies and purchase orders for the department
7. Exercises judgment in the retention, routing and destruction of data and confidential data
8. Responsible for writing and updating standard operating procedures (SOP), work instructions (WI), and policies on an as-needed basis.
9. Coordinate and respond to requests for product data/information, surveys/questionnaires requested by customers.

Carry out the above tasks with minimal supervision.



POSITION REQUIREMENTS (AS APPLICABLE):

EDUCATION:
Associate degree

LICENSES OR CERTIFICATIONS:
None identified

EXPERIENCE:
1. 1-2 years Regulatory Affairs experience in medical device and in vitro diagnostic device companies.
2. Understanding

SPECIAL SKILLS:
1. Proficient in using Microsoft Word, Access, Excel and Outlook.
2. Good communication and project management skills.
3. Must be able to handle multiple tasks.
4. Attention to details.

KNOWLEDGE OF SPECIFIC PROCEDURES/PRACTICES:
1. Knowledge of 510(k) (for both medical devices and in vitro diagnostic devices), IDE, MDD 93/42/EEC and IVDMDD 98/79/EC.
2. Knowledge of 21 CFR 820 -Quality System Regulation, and ISO 9001:2000.
3. Knowledge of standards and FDA guidance's.