 |
|
Compliance and Submission Officer
A Beauty industry equipment manufacturer located in the Denver, Colorado is in search of a strong leader to manage regulatory affairs. If you have strong management skills and a proven track record in FDA submission/approval activities, this could be an exciting opportunity for you! Background in device manufacturing required. Tremendous growth and income potential.
Main Tasks and Responsibilities:
In this role you will be responsible for oversight of all device approval functions currently impacting product operations as well as regulated product design and development, clinical studies, and regulatory agency liaison activities. Specifically, you will be expected to:
• Develop and implement strategies to assure effective product approvals with FDA as well as international regulatory agencies
• Prepare all FDA submissions including 510(k)s and PMAs, as well those required for international registrations such as EU technical files.
• Responsible for the preparation, coordination, and management of all meetings with the FDA and other regulatory authorities.
• Responsible for company compliance with all applicable global regulations including but not limited to advertising/promotion, MDR / vigilance reporting, recalls, issuance of advisories, etc.
• Manage preparation and submission of IRB clinical study conduct and documentation.
• Develop, establish and maintain quality engineering methodologies, systems, and practices. Provide focused quality engineering support within new product development.
• Maintain Risk Management documentation, SOP’s, Design History files, and GMP documentation and activities.
• Ensure Risk Management is effectively utilizing feedback from validation, field safety, CAPAs, HHAs, etc.
• Participate in product complaint and corrective action systems.
The Candidate
• This position requires a minimum of an undergraduate degree in a technical field relevant to the biomedical industry, preferably Engineering
• Minimum 5 years in a medical device industry.
• Extensive knowledge and experience protocol, as well as preparation and report writing
• Strong collaboration and development skills.
• Previous experience and contact with internal FDA personnel and protocol.
• Location – Denver, Colorado
• Salary and benefits negotiable
For more information please forward your resume or CV to ken@alliedhealth.net.
|
| Additional Information |
Position Type:
Employee
Ref Code: |
| Contact Information |
Kenneth Callison
ken@alliedhealth.net?subject=
Allied Health
5420 S Quebec Street Suite 102
Englewood CO 80111
303-662-9075 ext:
|
|
|
|
|
