The primary purpose of this position is to assume responsibility for developing and maintaining world class quality systems related to the design assurance and regulatory aspects of products in respective Product Category(ies) developed at site while developing employee efficiencies. The role is responsible for developing and leading a strong DA, RA, and Post Market teams to best-in-industry standards.
Accountabilities & Responsibilities:
- Adheres to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
- Responsible for the supervision and development of their respective team(s) which may be comprised of any combination of the specializations below:
- Design Assurance:
- Designs and executes product assurance programs to effectively develop and approve new products.
- Development and maintenance of product test methods.
- Develops and validates new test methods and/or measurement equipment to meet industry and regulatory standards.
- Prepares, reviews, and analyzes design history documents to assure technical accuracy, completeness, and compliance with applicable internal, regulatory and customer guidelines. Ensures accurate and complete design records are maintained.
- Prepares validations, verifications, risk analysis documents, and similar product assurance activities.
- Ensures test methods are in place to meet design specifications, customer requirement specifications and any required standards.
- Regulatory Affairs:
- Ensures regional compliance to all relevant regulations
- Manages the Regulatory request process
- Ensures all submission adhere to relevant regulations
- Reviews literature, and prepares studies as applicable, to collect data to support submissions to regulatory authorities and future product development.
- Approves customer notifications and sharing of technical information
- Approves Risk Management documents for respective product line
- Post Market:
- Manages the Complaint handling process
- Manages post market surveillance activities such as the creation of the PMS plan / report, gathering all required information such as obtaining customer feedback, review of complaints
- Review and recommend action as necessary on trended information for product families.
- Manages and evaluates quality issues including field alerts, recalls, or regulatory actions.
- Design Assurance:
- Collaborates cross-functionally with R&D teams and serves as an active member of the R&D group design phase reviews for the products developed, ensuring compliance to standards and regulations.
- Creates, reviews, and approves controlled documents as required, including protocols, reports, and document changes.
- Reviews and provides guidance on documentation to ensure a high degree of accuracy, completeness, and effectiveness.
- Creates, monitors, and develops appropriate DA, RA, & Post Market KPIs to drive compliance for Integer products.
- Interfaces directly and regularly with internal and external customers including regulatory agencies.
- Stays abreast of developments pertaining to engineering through contact with educational institutions and professional societies and perusal of trade and professional journals, texts and periodicals.
- Leads and mentors junior staff members.
- Performs other duties as required.
Education & Experience:
- Minimum Education:
- Bachelor's in Life Science discipline or equivalent combination of education and experience. Master's degree preferred.
- Minimum Experience:
- 10+ years of experience in a medical device development and manufacturing environment.
- Demonstration of strong writing skills in all job responsibilities
Knowledge & Skills:
- Special Skills:
- Able to partner effectively with internal and external partners in a proactive, positive and constructive manner.
- Able to manage multiple projects and timelines and accommodate multiple priorities in a fast paced and changing environment.
- Able to systematically identify and resolve complex problems with an analytical data driven approach and creative thinking.
- Able to demonstrate effective oral communication skills with personnel from various departments/levels.
- Organized and detail oriented, demonstrates a high level of commitment and drive for excellence, and generates enthusiasm.
- Specialized Knowledge:
- Demonstrated knowledge of U.S and EU regulatory requirements and standards as it relates to pre-market approval, interactions with regulatory bodies, post-market surveillance, risk management and oversight of corrections and removals.
- Understand how to access other geographical regulatory requirements if needed.
- Experience with product development, design verification, validation, risk management.
- Intermediate to advanced proficiency with MS Office Suite (Word, Excel, PowerPoint, Project, Outlook); Adobe Professional.
- Proficiency in reviewing, reading, analyzing, and interpreting general business periodicals, professional journals, technical procedures, and governmental regulations.
- Expert in writing reports, business correspondence, and procedure manuals.
- Keep informed of developments pertaining to engineering through contact with educational institutions and professional societies and perusal of trade and professional journals, texts and periodicals
- Travel: The position requires approximately 10% domestic and international travel.
- Must be in compliance with PRRC (Person Responsible for Regulatory Compliance) job specifications for this role (if applicable).