QA/RA Specialist 4/ Supervisor
This position is responsible for supervising a team of quality and regulatory professionals. The candidate will provide quality/regulatory guidance for the Diagnostics Division. Responsibilities include preparing and filing regulatory submissions to support R&D Systems’ products [510(k)s, Technical Files, and international regulatory documents], serve as primary contact for quality/regulatory issues related to assigned products. Experience with In Vitro Diagnostics, Controlled Manufacturing and Aseptic Processing a plus.
- Participate in Diagnostics Division (DD) team meetings as Quality/Regulatory representative, and serve as primary contact for quality/regulatory issues in the DD.
- Support implementation of quality objectives and plans to assist in maintaining the Quality Management Systems in the DD.
- Provide quality/regulatory guidance in the qualification and operation of the controlled manufacturing area in the DD.
- File appropriate documentation with regulatory agencies for R&D Systems’ DD products, including 510(k)s, technical files, and license applications.
- Respond to customer and supplier quality / regulatory requests regarding R&D Systems’ DD products.
- Participate in external audits by regulatory authorities, notified body, and customers.
- Work collaboratively with all functions to ensure conformance with all quality and regulatory requirements.
- Provide leadership in the DD to ensure compliance with internal and external quality requirements through policy and procedure development and implementation.
- Perform additional duties as assigned.
Education and Experience
This position requires a minimum of a Bachelor’s degree with 8 years of experience or Master’s degree with 4 - 6 years of experience in an FDA-regulated industry.
Knowledge, Skills and Abilities
- Expert knowledge of Quality Management Systems, including ISO 9001 and ISO 13485.
- Knowledge of regulatory requirements in global markets, including US, Canada, and EU.
- Excellent verbal and written communication skills including technical writing skills.
- Ability to provide organizational leadership by establishing, articulating and modeling the vision and goals; ability to guide others in a direction that aligns with same vision and goal.
- Ability to negotiate by collaborating with others to arrive at a conclusion using compromise, persuasion, rational, and diplomacy
- Skills in problem solving and critical thinking, including the ability to identify and appropriately evaluate an alternative course of action.
- Skills in planning, organizational, time management and multi-tasking.
- Ability to make effective decisions and execute an appropriate course of action which complies with quality and regulatory requirements while supporting business objectives.
- Knowledge of safety and company rules and policies.
- Ability to handle sensitive and proprietary information with discretion and confidentiality.