Senior Manager - Quality Assurance & Regulatory Affairs

Key Responsibilities:

- Responsible for development, implementation, maintenance, and overall success of the company's quality and regulatory programs and strategies, including articulating quality standards and objectives, developing methods to embed quality into the product development and manufacturing processes, establishing vendor relationships and quality standards, and developing and implementing innovative programs to focus employees on improving product quality.

- Develop, implement, and support a comprehensive regulatory compliance strategy to meet global market requirements for our products and ensure alignment with our overall business strategy.

- Proactively partner with R&D, Marketing, and other groups to provide regulatory advice and guidance on meeting necessary requirements to place products on global markets.

- Ensure that regulated processes and systems are always inspection ready.

\- Oversee the performance of internal and external audits.

- Review, edit, and maintain all departmental policies and procedures, including training, CAPAs, ECRs, and ECNs.

- Oversee the development of employees, talent, processes, and technology necessary to reach annual and long-term objectives as organizational leader for the QA/RAfunctions

- Serve as a person responsible for regulatory compliance (PRRC).

- Other duties as assigned.

Skills & Abilities

- Extensive experience hosting regulatory inspections and interacting with regulators

- Strong understanding of global registration requirements and demonstrated track record of successful market access.

- Experience with computer software validation (CSV) and implementation for QMSand ERP software packages, including user requirements gathering and specification development, process workflow documentation, validation script writing, and IQ/OQ/PQ test case execution

- General understanding of ICH, cGMP, cGDP, FDA, ISO, MDR, Healthcare compliance and applicable regulations and industry standards regarding clinical research and regulation of medical devices

- Effective manager with ability to mentor and develop members of the QA/RAteams through coaching and effective performance management

- Proven ability to create culture of accountability and ownership

- Proven track record with establishing and maintaining strong internal and external partnerships.

- Must be able to work effectively at all levels in the organization in a matrix environment and with external partners.

- Must demonstrate excellent written and verbal communication skills and work well with diverse teams and stakeholders in multiple locations.

- Must possess the ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities to meet deadlines and prioritize work on multiple projects.

- Highly independent and self-motivated and integrates well within a team.

Physical Demands

- Ability to travel.

Qualifications:

Bachelor's degree required in a science, engineering field or related discipline.

- MBA is a plus

Experience:

- 10 years of QMS experience and demonstrated leadership experience.

- Proficiency with ISO 13485, Good Clinical Practices (GCP), and Quality System Inspection Techniques (QSIT); CFR's parts 210 & 211.