"Alerted.org

**TITLE** : Quality Assurance & Regulatory Affairs Manager

**Department:** Quality Assurance / Regulatory Affairs

**Classification:** Exempt

**Reports To:** Senior Director of Quality Assurance and Regulatory Affairs

**Date:** XX Mar 2025

JOB SUMMARY:

Provide overall company leadership and direction for worldwide Tecomet’s Quality Assurance and Regulatory Affairs Systems, encompassing both improvements and sustaining activities. The Vice President of Quality Assurance and Regulatory Affairs will play a critical role in transforming and optimizing the Company's global quality and regulatory strategy, delivering operational excellence, and enhancing quality standards across the organization. Objectives involve ensuring patient and employee safety and the achievement of customer quality requirements, create, monitor and improve quality systems/programs, reduce quality costs and maintain compliance within FDA and ISO regulations. This is accomplished by maintaining Tecomet principles of Safety, Quality, Customer Satisfaction and Innovations.

ESSENTIAL FUNCTIONS:

+ Oversee and implement an advanced level of world-class quality systems for planning, design of experiments (DOE), ISO, quality function development (QFD), design for world-class manufacturability.

+ Take a leadership role as a Regulatory Affairs leader and mentor supporting functional team members. Integrate the regulatory function with manufacturing to ensure compliance to national and global regulatory requirements.

+ Develop regulatory strategies for North American, South American, EU, Asia, Australia markets.

+ Provide strategic leadership and oversight to the Global Quality Assurance and Regulatory Affairs function, setting clear direction and priorities that are aligned with the Company’s values and promoting a culture of quality excellence.

+ 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.

+ Design and implement an enterprise-wide organizational structure and regulatory governance

+ 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.

+ Provide regulatory guidance and support to project teams including regulatory filing strategies, testing and standards requirements and support RA staff in filing process.

+ Review, analyze and approve technical data generated by Research and Development, Manufacturing, Marketing, Clinical Research, Quality Assurance or other related.

+ Review promotional and advertising materials, complaints and lead vigilance and MDR reporting efforts.

+ Prepare US and International regulatory submissions, including, but not limited to IDE/IDE Supplements, 510Ks, PMAs/ Supplements, Annual Reports, Technical Files, and Design Dossiers and Change Notices.

+ Serve as Official FDA Correspondent.

+ Serve as person responsible for regulatory compliance (PRRC).

+ Assist and complete site FDA/ISO/AS/EAR Registrations

+ Host FDA and government and notified regulatory agencies audits.

+ Review and interpret regulatory rules as they relate to company products and processes. Set up Quality System policies and procedures to ensure is in compliance with FDA 21 CFR, Part 820, Quality System Regulation and EU requirements.

+ Review and interpret regulatory regulations related to Aerospace and Defense (ITAR/EAR/AS 9100)

+ Conduct ongoing company-wide trainings on FDA and ISO requirements.

+ Manage the CAPA process and ensures corrective actions are established and that root cause elimination is completed for identified issues.

+ Manage the Complaint Handling process and Medical Device Reporting activities.

+ Oversee the performance of internal and external audits.

+ Integrate the regulatory function with manufacturing as a value added (real-time) support function, optimizing the continuous quality improvement process, while reducing cost and improving customer relationships.

+ Design and facilitate the development of quality systems for a highly regulated medical device, aerospace, defense industries to achieve customer satisfaction, regulatory compliance and increase shareholder value. The objective is to devise systems that facilitate good products fast without compromise.

+ Acts as Management Representative in reporting to management on performance measures for quality improvements and compliance.

+ Assure Tecomet is conducting business within compliance to the National and Global regulations.

+ Provide organizational assessments to upper management.

+ Enhance the one company systems interface capabilities, whereas optimizing the capabilities to perpetuate harmonized systems improvements, and based on deploying the best practices from the collective experience contribution of the worldwide teams.

+ Ensure the quality systems focus remains on continual quality improvement, while aligned with internal and external customer expectations. The results/objectives are geared on achieving an error-free (flawless) process, which will deliver products on time with world-class quality standards for improving quality, operational excellence, customer experience, financial engine and generating new business.

+ Ensure the organization is basing improvement related decisions on factually/meaningful data, subsequently reducing waste and expediting the recognition of favorable results.

+ Leadership responsibility for promoting and developing Tecomet’s Environment Management System; Worldwide Quality Management Systems Software implementation/validation and harmonization (ETQ); New Product Development; and Worldwide Supplier Quality Systems.

+ Responsible for managing multiple sites to encompass global Quality Systems and Regulatory Affairs responsibilities.

+ May have Senior Managers and Directors reporting in a region.

+ Performs other duties or special projects as required or as assigned by supervisor.

KNOWLEDGE, SKILLS AND ABILITIES:

+ Strong organizational skills

+ Strong people and leadership skills

1. Diplomacy

2. Motivation

3. Teaching/Coaching/Mentoring

4. Creative

+ Verbal and written communication and listening skills

+ Problem solving and evaluation

+ Process improvement

+ Computer operation

+ Project management

+ ISO 13485/EN46001

+ EU MDR

+ AS 9100, ISO 9001, AS 13100

+ ISO 14001

+ ITAR/EAR

+ Federal and State laws and regulations

+ Knowledge of International Quality Standards

+ Knowledge of International Environmental Standards

+ Strong auditing background

+ Multi-task

+ Speak in front of people in a variety of settings

+ Be flexible and adapt to changes in the marketplace

+ Create and manage high performing work teams

+ Interface professionally and courteously with customers/public/internal staff

+ Prioritize work

+ Meet goals and objectives set for company

+ Make decisions in a consistent, professional manner

+ Maximize opportunities for the business

EDUCATION AND WORK EXPERIENCE:

+ Bachelor of Science in Engineering (ME, IE, BME) required Or Equivalent Experience

+ Six Sigma Black Belt certification (desirable but not essential)

+ Ten (10) to Fifteen (15) years of regulatory affairs and quality systems experience directly in medical devices is required.

+ Master’s degree (desirable but not essential)

PHYSICAL AND ENVIRONMENTAL DEMANDS:

+ Well lighted, heated/or air-conditioned indoor office/production setting with adequate ventilation.

+ Light physical activity performing non-strenuous daily activities of a primarily administrative nature.

+ Ability to maneuver throughout the facility/facilities as needed.

+ Manual dexterity sufficient to reach/handle items and work with fingers.

+ Ability to wear proper PPE.

+ Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

AMERICAN WITH DISABILITIES ACT (ADA):

+ Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER / PROTECTED / VETERANS / DISABILITIES / DRUG FREE WORKPLACE

TRAVEL REQUIREMENTS:** X **YES** **NO

**

INTENT AND FUNCTION OF JOB DESCRIPTIONS:

_Requirements, skills, and abilities included have been determined to be the minimal standards required to successfully perform the positions. In no instance, however, should the duties, responsibilities, and requirements delineated be interpreted as all inclusive._

_In accordance with Americans with Disabilities Act, it is possible that requirements may be modified to reasonably accommodate disabled individuals. However, no accommodations will be made which may pose serious health or safety risks to the employee or others or which impose undue hardships on the organization._

_Job descriptions are not intended as and do not create employment contracts. This organization maintains its status as an at-will employer. Employees can be terminated for any reason not prohibited by law._

_Tecomet is an Equal Opportunity Employer M/W/Vet/Disabled_