Portland, ME, United States
$70,000 - $100,000
almost 2 years ago
Manager of Quality and Regulatory Affairs
The Manager of Quality and Regulatory Affairs is an integral part of the clinical diagnostics’ management team with divisional and site-specific responsibilities. This position reports to the Vice President and oversees the direct management of the Quality and Regulatory Affairs staff at the Maine location with responsibility for the overall assimilation, implementation, and direction of the Division’s Regulatory Affairs with respect to the requirements of ISO 13485, U.S. FDA, the European Union, other international markets as deemed appropriate, and business partners. This position also functions as the Champion of the Division’s Quality Management System within the site and maintains compliance with Maine State regulations.
Divisional responsibilities include, but are not limited to, the following:
- Function as the subject matter expert for relevant Regulatory requirements, domestic and international, stay abreast of changes in regulations, and provide interpretive guidance.
- Coordinate and oversee all IVD product registration processes including but not limited to; regulatory body communications, pre-submission, U.S. FDA 510(k) clearance, U.S. FDA product listings, EU registrations and other international market registrations as deemed appropriate.
- Provide input into corporate strategy development particularly with regards to regulatory requirements for new products and services.
- Compile and maintain all necessary regulatory documentation for medical device reporting of adverse events to appropriate agencies.
- Maintain compliance monitoring program inclusive of international registration monitoring, export compliance, Foreign Corruption Practices Act (FCPA), and Research Use Only product monitoring program.
- Provide Regulatory guidance to cross-functional teams including Manufacturing, R&D, Sales, Marketing
- Manage Distributor relationships with regards to regulatory support and guidance.
- Coordinating with other site leaders, execute defined tactical and strategic changes to the QMS.
- Review and approve product labeling (IFUs, packaging, promotional materials, etc.) and manufacturing records with consideration of regulatory compliance.
Site responsibilities include, but are not limited to, the following:
- In accordance with the company’s Quality/Regulatory objectives driven by the Vice President of Quality and Regulatory Affairs, champion the QMS, ensuring its successful implementation and compliance with FDA and ISO 13485.
- Maintain site-specific ISO 13485 certification and CE registration.
- Maintain compliance with FDA, DEA, CDC, OSHA, DOT and EPA federal regulations.
- Plan and coordinate audits and needed training for personnel.
- Provide focused emphasis of the ownership of the QMS by all personnel.
- Manage and coordinate activities of staff to achieve Company goals.
- Serve as the LGC Maine Standards site Quality Management Representative.
Leadership responsibilities include, but are not limited to, the following:
- Support an environment which promotes positive communication and respect.
- Build and lead an effective and cohesive team, which may include off-site employees, with effective succession planning for the department.
- Help establish and support the core ideologies and core principles.
- Provide effective controls, covering non-financial as well as financial, in the department to support meeting both short-term and long-term goals of the Division.
- Bachelor’s Degree in a scientific discipline or Business Administration.
- 8+ years of related Regulatory experience in the medical device industry.
- IVD product registration/submission experience on a global scale, including, at a minimum, the US and EU preferred.
- Experience working within and perpetuating a strong QMS. Direct management of a QMS strongly preferred.
- Strong experience working within a U.S. FDA and ISO 13485 registered manufacturing facility.
- Proven management experience with strong cross-functional relationship building skills.
- Occasional travel, including domestic and international, is required.