JOB TITLE: Global RA/QA Director, Specialty EyeCare
DEPARTMENT: Regulatory Affairs JOB SUMMARY
The Director of Regulatory Affairs and Quality Assurance, Specialty EyeCare Division is responsible for the development, implementation, and maintenance of the applicable regulatory and quality system requirements for all the Specialty EyeCare products and markets. The Director of RAQA will ensure compliant design, manufacturing, and distribution processes according to 13485:2016, 21 CFR 820, and other quality system requirements. The Director is responsible for site and product registrations according to the applicable country/market requirements including the US, EU, China, and other markets. This position oversees RAQA resources and is responsible for establishing a state of ‘audit readiness’, in support of successful regulatory audits. The Director is the senior RAQA position in the Specialty EyeCare Division and a member of the division leadership team. The Director role is accountable and given the authority to manage, resource, and guide the RAQA organization.
- Responsible for the Quality Assurance and Regulatory Affairs processes and staff across the Specialty EyeCare Division sites.
- Represent RAQA as a member of the Specialty EyeCare Division Leadership Team.
- Guides, plans, and directs the RAQA staff to create and/or maintain compliance to the applicable regulatory requirements.
- Ensures the processes needed for the Quality Management System are established, implemented and maintained.
- Ensures regulatory affairs processes are conducted to current country regulations and requirements.
- Determines and provides quality system requirements in accordance with current regulations and customer requirements.
- Integrates quality and regulatory planning, in collaboration with other functional leaders, in planning for new or modified materials, products, components, equipment, or processes.
- Responsible for the regulatory projects, from pre-clinical stage through to final approvals/clearance, in support of timely approvals for new or revised products.
- Coordinates with other functional leaders to review and agree registration timelines and resource requirements.
- Contributes to the achievement of division objectives and maintenance of the quality management systems. through strategic planning; quality objectives and targets; regulatory objectives, and continuous quality improvement.
- Ensures that the performance of the Quality Management System is communicated to division leadership including any areas of improvement.
- Leads and provides technical expertise in the validation, verification, and qualification processes used across the Specialty EyeCare sites.
- Coordinates with the design, manufacturing, and distribution functions to analyze and improve the effectiveness of the Quality Management System.
- Guides and collaborates with the Specialty EyeCare leadership team to define and establish a culture of quality.
- Ensures quality and regulatory training is adequate and conducted across the various levels of the Specialty EyeCare Division organization.
- Determines and communicates regulatory changes and requirements applicable to the Specialty EyeCare Divisions products and processes.
KNOWLEDGE, SKILLS AND ABILITIES
- In-depth understanding of the 21 CFR 820, ISO13485:2016, and other quality system requirements as required by the countries/markets where Specialty EyeCare products are distributed.
- Working knowledge of registration requirements and processes for countries/markets where Specialty EyeCare products are distributed.
- Strong leadership skills characterized by the ability to work at multiple levels of the organization in order to drive results.
- Proven track record of effective people management including coaching and development planning.
- Able to guide/direct a culture of quality and develop/support his/her reports to achieve superior results.
- Strong project management skills combined with managing multiple tasks effectively.
- Proven team player and experiencecollaborating with the Sales and Marketing, Manufacturing, and R&D teams.
- Able to lead and direct the integration and continued participation in the Medical Device Single Audit Program (MDSAP) at the applicable sites.
- Strong technical and analytical skills, including statistical tools, used in the development and manufacture of Specialty EyeCare products.
- Ability to manage and provide technical expertise regarding production controls, e.g. validation/verification testing, master validation plans, and engineering change controls.
- Able to effectively utilize quality system feedback and improvement processes to continually improve Specialty EyeCare products, production, and distribution.
- Demonstrated ability to lead strategically, drive performance, and act collaboratively.
- Ability to deal with conflict through clear communication and strong negotiation skills.
- Sufficient organizational agility to quickly adapt to change and redirect resources effectively and appropriately.
- Highest levels of personal and professional integrity and ethics, and unquestioned integrity in each of his/her initiatives
- Normal office and Manufacturing environment
- Travel is required (up to 40%)
- Bachelor's level degree, required
- Master's degree, desirable
- Minimum of 15years of experience in the Medical Devices Industry
- Minimum of 10 years of RAQA management experience
- Strong knowledge of regulatory and legal requirements related to product registration processes for Medical Devices.
- Application of quality system and regulatory requirements from product concept through product distribution.
- Working knowledge of interacting with regulatory entities, notified bodies, and other external regulators.
- Contact Lens experience is highly desirable
- Works effectively across different cultures and languages
- Strong technical acumen, computer skills, problem solving ability, analytical, writing and communication skills.
- Experience working in both a large multi-national company and small entrepreneurial company setting.