Summary Description

The Quality and Regulatory Affairs Manager is responsible for the maintenance of the Quality System compliant to the ISO 13485 standard for Class I and all Devices and FDA medical device requirements including internal audits and training activities. This position is also responsible for keeping abreast of any regulatory requirements or changes applicable to the product in worldwide target markets and communicating these requirements to Executive Leaders. This position will support all regulatory submissions for the product including FDA 510(k) submissions and submission and maintenance of CE-Technical Files for the product.

Essential Duties and Responsibilities

Subject matter expert in Quality and Regulatory compliance, contributing to attaining and maintaining the required registrations/certifications to sell product globally.

Manages and oversees the Quality Management System; ensure best and most current practices are leveraged company wide.

Collaborates internally and externally to determine customer requirements and ensure they are met.

Partners with critical suppliers to maintain the highest rate of supplier performance and compliance.

Establishment and use of metrics to monitor the suitability and effectiveness of the QMS.

Develops, maintains and follows ISO procedures and GMP requirements pertaining to medical devices.

Responsible for managing the RMA, QC Inspection, document control personnel & processes, Acceptance Activities, Calibration Process, Quality Management System (QMS) Training Process, Material Review Board, and Quality Engineering activities.

Advises personnel and project teams on quality system and regulatory requirements, coordinates and presents regulatory information, and negotiates with and influences management and colleagues to ensure requirements are met.

Ensures that company and quality system are compliant with all federal, state, local and company specific regulations as they apply to medical devices or a medical device facility; responsible for ensuring that internal and external audits are performed per current regulatory guidelines/procedures.

Coordinate with external consulting resources as needed.

Manage the Internal Audit, CAPA program and Supplier CAPA program.

Work with process owners of CAPAs and internal audit findings and ensure appropriate corrective actions plans are implemented and verified for effectiveness.

Provide oversight to the on-going maintenance of the Quality System procedures; ensure that changes to the procedures are consistent with the intended structure of the Quality System.

Knowledge, Skills & Abilities Required:

Education and/or Experience:

Minimum of a 4 year degree from an accredited university.

ASQ CQA and/or CQE certified.

Strong knowledge of ISO/FDA regulations and procedures for medical devices.

Familiar with the FDA 510(k) submission process, ISO 13485 standard and CE marking activities.

Familiar with FDA Establishment Registration, FDA Device Listings, FDA Certificates to Foreign Government.

Experience as a cross-functional project manager (i.e. can effectively work with legal, marketing, sales, engineering, IT, support, and operations groups).

Familiar with technical details of medical devices concepts, practices, and procedures.

Ability to read, analyze, and interpret standards and regulations.

Ability to manage critical projects to deadlines as part of an interdisciplinary team.

Strong interpersonal, oral and written communication skills with the ability to effectively communicate with all levels of the organization, customers and suppliers.

Presentation skills, technical writing and editing skills.

Strong attention to detail and excellent organizational skills.

Ability and willingness to work flexible/extended hours and light travel may be needed to support the business.

Language Skills:

Read, write, and verbally communicate in English.

Computer Skills:

Proficiency in using the personal computer, including Windows-based applications.

Reasoning Abilities:

Ability to define problems, collect data, establish facts, and draw conclusions.

Person must be resourceful and a self-starter.

Ability to prioritize and multi-task.

Authority

Initiate solutions to quality related problems.

Prevent non-conforming product.

Make and implement decisions within their areas of responsibility.

Physical/Mental Demands:

Must be alert, able to concentrate, able to use good judgement and analytical skills.

Able to sit, stand and perform repetitive activities for sustained periods of time.

Uses hands to type on standard pc keyboard frequently.

Works in normally stressful environment with significant pressure.

Move about facility to interact with employees.

Multi-task on several jobs at once.