Greater Portland Area, United States
$70,000 - $90,000
about 1 year ago
Are you looking for the chance to oversee a successful medical devices company’s regulatory tasks and goals? Do you flourish in a successful but casual work environment? Are you wanting to make the next step in your career?
Then look no further, because this is the chance to assume responsibility for an organization’s upcoming regulatory requirements.
A small and successful medical mevices company are looking for a full-time Quality Assurance and Regulatory Affairs Director for their corporate headquarters located in the Greater Portland Area. They are focused in the areas of anesthesia, respiratory and critical care medical devices and are a specification developer.
By designing, manufacturing, and wholesaling devices to have unique technologies that positively affect patient outcomes and extract cost from the healthcare delivery system, they are experiencing year on year growth of over 17%, and last year hit the $2.5million mark. The Director is responsible for managing Quality and Regulatory activities to support all aspects of their Quality and Regulatory programs.
- Preparation, organization, and coordination of data for submissions to the FDA or regulatory agencies: i.e. 510(k), MDD/MDR Technical Files for class I and II devices.
- Manage correspondence with regulatory and standards agencies or organizations such as FDA, Notified Body, Competent Authorities.
- Ensures compliance to ISO 13485:2016, FDA regulations, MDSAP, EU MDD regulations
- Develops company regulatory strategies and determines priorities to create, develop, and maintain materials for regulatory compliance.
- Management Representative for the Quality System, which maintains compliance to FDA/QSRs, ISO 13485:2016, MDSAP and EU MDD requirements.
- Facilitate worldwide product registration activities by compiling appropriate dossiers, submissions and responses to regulatory bodies.
- Execute requirements for international product registration, including certificates for foreign governments including renewal or changes.
- Maintain information on worldwide regulatory requirements and the status of product registrations.
- Lead the preparation and execution of ISO, FDA, and other regulatory agency audits and the development of IFUs and labeling.
- Oversee quality operations and coordinate quality duties throughout company.
- Qualifies and monitors vendors.
- Support and participate in the quality objectives within the company.
- Reviews, approves, verifies, and participates in Corrective Actions.
- Analyzes quality data on a regular basis.
- Completes the duties described in the Quality Assurance Manual and monitor internal auditing system.
- Provide training to personnel on quality and other procedures.
- Minimum of 3 years’ Regulatory Affairs experience within medical devices, with FDA, EU and manufacturing exposure.
- Bachelor’s degree in a science related field.
- Experience in medical device manufacturing preferred.
- Thorough knowledge and experience in FDA, MDSAP, ISO, and MDD requirements and consensus standards.
- Exceptional organizational skills with extensive knowledge of business software i.e. MS Office.
Strong verbal and written communications skills with the ability to communicate at all levels of the organization.