Director/Sr. Manager of Quality and Regulatory Affairs

A Philadelphia PA area Medical Device firm is searching for an experienced Quality Assurance and Regulatory Affairs leader. In this newly defined role, the Director/Sr. Manager of Quality Systems and Regulatory Affairs will focus on the following issues:

Quality Assurance - responsible for the Company's Quality Assurance systems and compliances regarding implementation and maintenance of the Quality Management System as per current U.S. and international regulations, standards and guidance documents. Familiar with a variety of Medical Device concepts, practices, regulations and procedures.  Relies on extensive experience and judgment to plan and accomplish goals.  

Regulatory Affairs - responsible for the Company's regulatory compliance regarding FDA, ISO, Medical Device Directive and CE Marking requirements inclusive of standards and guidance documents, provide regulatory advice and counsel to the organization, and serve as liaison and lead the company's efforts with all FDA and international regulatory submissions.

Quality Assurance -
1.Maintain the total Quality Management System, responsible for ensuring compliance to ISO 13485:2003 and other applicable standards as well as internal procedures
a.Serve as Management Representative
b.Conducts Management Review Meetings
2.Oversee ISO and GMP related employee training
3.Oversee quality control of finished products, including oversight of prouct / in-process testing
4. Communicate quality issues to R&D, Production and Purchasing
5. Approve and maintain product specifications, work instructions, and other documentation
6.Maintain document control system
7. Participate in Design Control
8. Educate employees on QA Systems requirements, compliance expectations, and helps prepare organization for FDA, ISO and other external audits.
9. Performs audits per FDA / ISO requirements
10. Participate in quality audits of suppliers and assure quality of incoming materials as needed.
11. Partner with Operations and R&D to ensure that appropriate quality standards are established and maintained.

Regulatory Affairs -
1. Provide project specific regulatory strategic plans
2. Prepare, review and authorize all U.S. and international regulatory submissions in accordance with all appropriate standards and requirements
3. Foster and maintain relationships with regulatory authorities to facilitate interactions on behalf of Xylos; act as primary contact with the regulatory authorities
4. Oversee development of  overall plans regarding safety, efficacy and quality to assure viability for global registrations
5. Reasearch regulatory requirements for assigned geographies. Monitor emerging trends and integrate new requirements into departmental procedures to insure the Company's compliance with all applicable regulatory requirements
6. Identify risk areas and develop alternative course of action including anticipation of regulatory responses (scenario planning and development of contingency plans)
7. Develop and manage budget as appropriate
8. Other such duties as may be assigned.
9. Collaborate with Marketing in the development of the Company’s marketing, labeling and product release strategies.
10. He/she will be responsible for hiring, training, assessment, and management of future quality and regulatory employees and contracted resources.



Requirements:
QUALIFICATIONS/TRAITS/CHARACTERISTICS:

1. A minimum 7 years of FDA / ISO / Quality Assurance experience in medical devices
2. Solid experience and proven track record in successful FDA and CE Mark submissions formedical devices
3. Current knowledge of FDA and international Quality Systems regulations, including monitoring and enforcement practices.
4. Bachelor's degree or higher in scientific field applicable to oversight of medical devices
5. Proven leadership, persuasiveness, initiative, adaptability, and communication skills
6. Strong writing, presentation and computer skills
7. Ability to simultaneously manage multiple projects in a dynamic environment
8. Ability to work in a collaborative team environment


e-mail responses to: DTucker@curraninternational.com