SUMMARY

This position oversees the Quality System/Operations and Regulatory Affairs, functioning as an independent and objective body that reviews and evaluates quality and regulatory issues/concerns within the organization.

The position ensures the management and employees are in compliance with the rules and regulations of regulatory agencies and that company policies and standard operating procedures are being followed.

Essential Duties and Responsibilities include the following.  Other duties as necessary.

Regulatory Compliance:

·         Ensures appropriate quality management system requirements have been effectively established and implemented to maintain compliance with US FDA’s Quality System Regulation, the European Medical Device Directive, ISO13485, and other relevant domestic and/or international regulatory requirements.  Communicates the status of the quality management system at management review through the use of established metrics.

·         Ensures the Quality Policy and Manual have been effectively established, communicated, and implemented to maintain compliance with domestic and/or international regulatory requirements.

·         Oversee the monitoring of post market surveillance, including product complaints.  Ensures CAPA’s are implemented as required to maintain suitability of both products and the Quality System

·         Ensures Quality Management System audits are planned, performed, results reported to executive management, and necessary / required corrective and/or preventive actions are taken in accordance with established procedures.

·         Oversee risk management process, including post-production risk.

·         Oversees Recalls and Field Removals.

·         Serves as the primary corporate liaison or contact with domestic and/or international regulatory agencies (e.g., FDA inspectors, Notified Body Auditors) regarding the Blackstone Medical Quality Management System.  Serves as the Management Representative.

Quality Assurance:

·         Ensures approved methods and procedures for the inspection / verification of products, goods and services are established and implemented

·         Ensures the calibration program for inspection, measuring and quality testing tools, gauges and fixtures is implemented; investigates and resolves reported out-of-tolerance conditions potentially affecting product quality

·         Oversee materials review board, ensuring proper disposition of all non-conforming materials.

·         Oversee Supplier Quality including:

Ø       Development of contractual agreements with supplies and contracts to ensure compliance with company policies and procedures and domestic and international quality system requirements for medical devices.

Ø       Ongoing qualification of suppliers and vendors through completion of supplier corrective actions.

Ø       Audits and ongoing statistical analysis of receiving inspection data.

·         Oversee employee training to insure FDA and EN requirements are met.

·         Ensure traceability of product, consistent with the regulations and the risk of the device.

·         Oversee device history record review.

·         Oversees Documentation system and ensures Good Documentation Practices are implemented.

·         Oversee the review and approval of product and manufacturing changes for adherence to quality system requirements.

·         Oversee the review and approval of the release of new products to ensure adherence to internal quality assurance requirements.

Regulatory Affairs:

·         Plan, budget, and implement domestic and international regulatory strategies for new and modified devices.

Ø       Assure consistency and quality of submissions, through technical guidance to staff during the course of strategy formulation and submission formulation.  Review and edit submissions.

Ø       Monitor prevailing and evolving FDA and international regulatory requirements and environment.

Ø       Oversee and maintain relationship with FDA through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up submissions under review.

·         Oversee device labeling and advertising materials for compliance with US and international labeling regulations.

·         Review marketing collaterals to ensure that information is congruent with data collected by the company, and is accordance with applicable regulatory requirements

·         Maintain device listing and establishment registration.

·         Oversee product and manufacturing changes for development projects for impact to current and future applications, and to ensure verification/validation activities are appropriately executed.

Supervisory Responsibilities:

Direct supervision of management employees.  Indirect supervision of professionals and non-exempt employees.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.   Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The position requires a pro-active, problem solving individual who is able to manage a varied workload with constantly changing priorities.   Must have excellent listening, oral and written communications skills.   The employee must be able to develop and maintain positive rapport with a wide variety of contacts both internal and external to the organization.  The ability to design, plan and implement programs is essential to the position.

Must possess excellent organizational skills and demonstrate flexibility as well as an ability to work under pressure.  Conflict resolution skills, negotiation skills and effective presentation skills to audiences of all levels are required.  Positive attitude towards the job and people is required.   

Proven leadership ability as defined by the following competencies and demonstrated in previous work experience:

·         Initiative/Risk Taking                                      ·        Motivating/Energetic/Team Building

·         High Quality & Extraordinary Results                  ·        Problem Solving/Decision Making

·         Delegating                                                    ·        Planning/Goal Setting

·         Vision/Strategic Focus                                    ·        Technical Competency

·         Effective Communication                                 ·        Mentoring

·         Coaching                                                     ·        Personal Integrity

·         Creativity/Innovation/Continuous Learning          ·        Empowerment

·         Customer oriented                                         ·        Emotional Maturity

·         Team Player/Collaborator

Education and/or Experience:

Bachelor’s Degree required.  Some post graduate education preferred with emphasis in business or law.  Ten to fifteen years experience in the medical device field with specialization to include quality control, quality assurance, quality engineering and regulatory affairs.  Previous experience with medical devices to include submission of 510 (k)’s, registration of products and response to federal, state and specialized regulatory agencies, audits and required programs.  Clinical Operations experience preferred.

Language/Mathematical Skills:

Language Skills Required

à        The ability to read, analyze and interpret documents, procedures, general business periodicals and professional journals.

à        The ability to develop and write reports and correspondence relating to a broad range of functional activities.

à        The ability to understand and explain complex issues to a diverse population.

à        The ability to write reports, business correspondence, procedures and persuasive presentations.

à        Ability to make effective and persuasive presentations on complex or controversial topics to a diverse internal or external population.

Mathematical Skills Required

à         Ability to work with mathematical concepts including probability and statistical process control, ANOVA and design of experiments.

à         Ability to calculate figures and amounts such as percentages and discounts.

à         Must be able to quickly apply the above math concepts to complex situations.

à         Ability to review summary figures, identify trends and analyze impact relative to areas of responsibility.

à         Knowledge and experience in budgeting and cost/revenue projections.

Decision Making/Problem Solving Skills:

The position requires the ability to independently solve complex problems and deal with a variety of concrete variables while developing general policy guidelines. The employee must be able to develop and apply a variety of instructions furnished in written and oral form and from multiple sources. 

Must be able to define problems, collect necessary information, establish facts, draw conclusions and take appropriate action.  Employee is empowered to make decisions directly affecting their ability to perform the above duties and responsibilities.

Reasoning/Analytical Skills:

Demonstrates critical thinking in their ability to define complex problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instruction in mathematical or diagram form and deal with several abstract and concrete variables.   Ability to analyze business situation and extract critical elements for decision making process, present them as alternatives with associated risks and describe the recommended solution from a business standpoint.  Must be able to develop processes and procedures as well as identify when the processes and procedures do not apply in a specific situation and handle exceptions as needed.  The position requires the ability to develop priorities and adjust work plans to meet deadlines not only for the employee, but also for their staff and project team members.

Certificates, Licenses, Registrations:

Membership/Certification in American Society of Quality, Regulatory Affairs Professional Society, Health Care Compliance Association and other applicable organizations would be a plus.  Experience in working outside the business group in community service arenas is also desirable.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Position is primarily sedentary and employee may be required to sit for extended periods of time working with a computer.  Standing, walking and meeting activities are also required throughout the work day.  Employee must be able to utilize a computer and telephone.  Normal sight or corrected vision is required to read documents and use standard computer terminals.

Work Environment:

Employee will work in private office area with a minimal noise level.  Employee will perform complex job tasks while experiencing numerous interruptions.  The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct.