Purpose:

To lead the company in all matters of quality assurance and regulatory affairs and act as the face of the company to the FDA for all compliance issues.

Duties & Responsibilities:

• Responsible for leading company product quality and reliability process, systems, and culture to meet and exceed customer expectations.
• Provide management and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes to gain product approvals.
• Adheres to the Integer Values and all safety and quality requirements including but not limited to EN ISO13485, the EU Medical Device Regulation and 21 CFR Part 820.
• Support all aspects of the centralized Regulatory Affairs function for the assigned Product Category including product registration, customer support and post-market surveillance.
• Responsible for Product Category level leadership, planning, coordinating, communication, organizing, coordinating, budgeting, staffing, metrics, and achievement of performance standards.
• Serves as principal Quality contact and advocate to customers in assigned Product Category and represents Quality Assurance in Product Category customer business reviews, executive partnership meetings and customer escalation events.
• Reviews and approves Customer Quality Agreements for sites and product category in alignment with Enterprise QA/RA and the Legal function.
• Through leadership of site Quality management and Operations, ensures that all key quality metrics are used to drive continuous improvement and that agreed improvement targets are attained as the result of clearly defined action plans.
• Lead the Design Assurance management team within support of new product development.
• Collaborate with Engineering to assure robust designs that result in safe and effective products of superior quality.
• Identify, resolve, or escalate any and all product, process or customer quality related issues that pose risk with respect to the patient, customers or compliance.
• Interviews, hires, and establishes training plans for direct reports and holds managers accountable to do the same. Provides leadership to assigned staff regarding development of individuals’ goals and mentoring of the group.
• Provide regulatory review and approval of product labeling, promotional claims, and advertising to ensure compliance with corporate policy, and US and international laws and regulations.
• Direct long and short-term departmental planning including structure, headcount, budgeting, training, and systems requirements.
• Manage internal and external regulatory procedures to ensure compliance.

Knowledge & Skills Required:

• BS in engineering, technical or related discipline. Master’s degree preferred.
• Minimum of 12 years of experience in Quality Assurance in a medical device development and manufacturing environment. Minimum of 5 years of direct management experience in a medical device development and manufacturing environment.
• Extensive experience with product development, design verification, validation, and risk management.
• A successful track record with game-changing first-of-a-kind product launches.
• Team player with excellent communication skills, both written and verbal.
• Flexible to work long hours as required.
• Experience with robotic surgery product development.
• Experience in the dental implant industry.
• Start-up experience.
• Experience with the following regulations (preferred):
• FDA 21 CFR Part 820 – FDA Quality System Regulation
• ISO 13485 -Medical Devices Quality Management Systems – Requirements for Regulatory Purposes
• European Medical Device Directive 92/43 EEC
• CAN/CSA-ISO 13485 – Medical Devices – Quality Management Systems
• Canadian Medical Devices Regulations (CMDR)

Physical Requirements:

• Able to work in an industrial environment.
• Capable of lifting at least 50 lb of weight.

Location: Miami, FL