Mgr. QA/Regulatory Affairs Salary: $90,000 - $110,000
Buffalo, NY
Submit resume to Greg Taylor - gtaylor@excelsiorsp.com
Refer to job TE01595383-0811
Description
We are seeking a top notch Regulatory Affairs Professional for a leading research and manufacturing firm. Put your QA, Regulatory and Medical Device expertise to work in a new position today!!!
Responsible for the Quality Assurance and Regulatory Affairs program, including compliance of systems to regulations. Must have medical device manufacturing experience. Appraise senior management of applicable regulations and current status of compliance and efficiency of quality systems. Appraise engineers and staff on current regulatory requirements pertinent to their job responsibilities. Responsible for quality engineering phases in new product development and manufacturing. Insures compliance to all regulatory requirements of products prior to release. To assure all products are safe and effective for use on the market. Manage all aspects of appraisal/evaluation and prevention phases of product quality.
Permanent position with an employee-centered company offering great benefits, salary and relocation assistance.
Position Duties and Responsibilities:
Manages the corporate quality program assuring compliance to agency regulations and corporate objectives
Develops, recommend and implement policies, procedures and practice including: Quality manual, SOP's and department procedures
Coordinates and collaborates with other functions in establishing and fulfilling responsibilities
Manages the CAPA and complaint systems
Coordinates in conjunction with the direction of NPD, engineering, Aid in systematic transition of product from project development through production, product release and manufacturing
Provides training on regulations and quality systems
Qualifications:
The qualified candidate will have:
- BS or advanced degree, preferably in a scientific/healthcare field, or equivalent.
- Minimum of 5 years experience within medical device.
- Ability to review clinical protocols, informed consents, monitoring and data management plans and independently make recommendations for improvements, where necessary.
- Previous demonstrated experience in, and responsibility for budget, staff management, quality systems, CAPA progress reporting.
- Ability to promote teamwork demonstrating excellent interpersonal skills.
- Sound use of engineering judgment.