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Regulatory Manager

Location: Philadelphia, PA; Pittsburgh, PA; Trenton, NJ; Wilmington, DE

Posting Number: 16805
Job Title: Regulatory Manager
Location: Philadelphia, PA; Wilmington, DE; Pittsburgh, PA; Trenton, NJ
Willing to Relocate: No
Compensation: $100K
Education Requirements: 4 year Degree

View MapPhiladelphia, PA; Pittsburgh, PA; Trenton, NJ; Wilmington, DE

Information

Contact Information

The SearchLogix Group

resumes@searchlogixgroup.com" class="linkNarrow">resumes@searchlogixgroup.com

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Compensation

Pay Rate: $100K

Apply: Complete your candidate profile at www.searchlogixgroup.com and refer to posting 16805 or as a second choice, email your information and requirements to resumes@searchlogixgroup.com. Only candidates who appear to meet the above criteria will receive an immediate response. Other resumes will be added to our database of active candidates for one year for other positions that come available and are a match with their background.

Features

Company Name: The SearchLogix Group

Industry: Medical Device, Manufacturing

Occupation: Regulatory Manager

Position ID: 16805

Employee Type: Employee

Status: Full Time

Required Education: 4 Year Degree

Required Experience (Yrs.): 5+ years

Attributes

Responsibilities

Manage and organize the Regulatory Affairs department ensuring that departmental objectives are implemented in line with the overall quality/corporate goals

Write and maintain procedures relating to the regulatory affairs function, the preparation and presentation of quality reports, data and key performance indicators for management reviews

Provide regulatory support as required in the evaluation of customer complaints, ensuring complaint reports are closed out in accordance with the approved procedure

Responsible for ensuring post market surveillance/vigilance systems, liaising with others in the quality departments, QA/QC

Ensure staff understands and complies with the requirements of cGMP as applies to the companys product and provide related training and support to departments as needed

Required Skills

4 year Degree in quality or science (chemistry, biology, or medical technology)

5 years related experience in a drug manufacturing, medical device, or biologics industry in regulatory affairs

Expertise in cGMPs, FDA regulations, and SOP development

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