Atossa Genetics is a cutting edge medical diagnostic company specialized in early breast cancer diagnosis, monitoring, and treatment.
We accept enthusiastic, high quality undergraduate or graduate students interested in learning the industry as interns. Stipend may be awarded depending on the skills and experiences. Please send your resume and contact information for two references to email@example.com.
Vice President Quality Assurance and Regulatory Affairs
The Vice President Quality Assurance and Regulatory Affairs (VP QA/RA) is responsible for driving the quality and regulatory activities for the Quality Management System (QMS) implementation across the Organization and ensuring contract manufacturer(s) are in compliance as well. The VP QA/RA, acts as Management Representative, and is the Company’s primary contact with the FDA, international regulatory agencies and outside auditors. The Vice President Quality Assurance and Regulatory Affairs plays a critical role in the Company’s Quality System Requirements and must have an overall understanding of Quality requirements with respect to FDAs Quality System Regulation, ISO-13485—2003, Canadian Medical Device Regulation and European Medical Device Directive (MDD) and other national or international regulations for where the Company plans to conduct business.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Establish, maintain and monitor ongoing Company-wide quality and compliance with applicable FDA QSR /ISO13485 standards, Canadian Medical Device Regulation and EU MDD, including reporting, records, training, systems and processes that ensure the Company’s quality system is functioning properly.
- Maintain accurate and timely reporting of quality management system effectiveness to Executive Management.
- Oversee all aspects of ongoing and new regulatory submissions, U.S. and International 510(k), TPG licensing, CE Marking etc.)
- Provide strategic direction and guidance to Executive Management regarding quality & regulatory timelines for new and revised products and/or processes, and/or regulations & guidance’s.
- Establish and maintain a quality culture of compliance within throughout the organization.
- Coordinate implementation and effectiveness of all quality systems activities at applicable manufacturing locations.
- Directing regulatory and quality strategy related to product development operations and testing programs.
- Implement and manage systems to audit, evaluate and approve the policies, procedures and practices impacting the quality and operations of the Company.
- Direct all activities for regulatory compliance within new business opportunity projects. These include quality agreement, validation, audit and site transfer activities.
- Direct programs to audit and implement follow-up actions to ensure that external supplier of components, packaging supplies and contract manufactured goods are in conformity with regulatory agency commitments and requirements
- Work with contract manufacturers to assure their compliance levels are maintained.
- Assume lead role in training managers in the quality system requirements.
- Establish a network of cross-functional teams to ensure the quality system performs in an effective manner.
- Build a strong and cohesive team that executes objectives with intensity and focus.
- Establish and maintain effective working relationships with the Sales and Marketing, Operations and Product Development Groups as well as regulatory counsel and outside consultants.
- Directs the needs assessment for training and staff development to enhance the effectiveness of employee performance in achieving the goals and objectives of the company’s quality management system
EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED
- Bachelor’s degree in Quality, Business Management, Engineering or related field is required; advanced degree a plus.
- Extensive knowledge of FDAs Quality System Regulation and ISO-13485 regulatory requirements governing the manufacturing of Class I and Class II medical devices. Also knowledgeable of international standards such as Canadian Medical Device Regulation & European Medical Device Vigilance Reporting.
- Ten to Fifteen (10-15) years’ experience in Quality Assurance and Regulatory Affairs in roles of increased responsibility with at least three to five (3-5) years’ experience at the Director level or above; and Class I and/or Class II medical device manufacturer experience.
- Previous experience in the manufacture of high volume low-cost electronic and mechanical products with emphasis on contract manufacturers.
- Experience preparing FDA 510k and CE mark submissions and documentation and international device license and registration (i.e. Canada, Japan, Australia etc.)
- Demonstrated ability leading and responding to FDA/ISO/MDD audits.
- Exceptional inter-personal and written and verbal communication skills to direct staff and cross-functional teams.
- Ability to manage and prioritize multiple projects and organize departmental resources to meet business objectives.
- Proficiency in MS Word, PowerPoint, Project, Excel and Access.
- Travel up to 30% to domestic and international operations & suppliers.
To apply for this position please send your resume to firstname.lastname@example.org.
If you are interested in employment at Atossa Genetics:
Please send your resume and the contact information of two references to email@example.com or send an email for more information.