Regulatory Affairs and Quality Assurance Director
The Regulatory Affairs and Quality Assurance Director is responsible for regulatory compliance and quality assurance programs of Inogen. This position ensures global product and operational compliance related to Class-2 (and accessory) medical device design, manufacture and sales; obtaining regulatory approvals; and establishing and maintaining quality and environmental management systems in keeping with business objectives. The Regulatory Affairs and Quality Assurance Director oversees regulatory inspections and ensures the timely filing of documents, records and reports with various regulatory agencies. Manage quality assurance and regulatory affairs activities per approved budget and annual operating plan
Responsibilities (Specific tasks, duties, essential functions of the job)
Obtain and manage all necessary domestic and international regulatory registrations, product clearances/ approvals, certifications or other documents required to maintain ISO 13485-2016, MDSAP and FDA registration to facilitate the sale of Inogen products in US, State of California, European, Canadian, China and other international markets as determined by business objectives.
Maintain documentation needed to support FDA, ISO and EU/ international compliance, allowing for the sale of Inogen products in US, EU, Canadian and other international markets, as determined by business objectives.
Compile, submit, and monitor reports and responses to regulatory authorities.
Assist with coordinating inspections of Inogen, its subsidiaries, and contract manufacturers.
Design, implement, and maintain an Internal Audit Program company-wide for a fully compliant Quality Management System (QMS) - including within its scope applicable accreditation and Home Medical Equipment (HME) for Durable Medical Equipment (HME) compliance provisions - and Environmental Management System (EMS). Grow program and provide support as additional sites/ operations are added subject to Inogen's QMS.
Lead and conduct or support second-party supplier audits, as needed.
Manage post market surveillance (PMS) and vigilance activities, including customer complaints analysis/adverse medical event reporting systems, clinical reports, etc. and verify actions taken to improve product quality are appropriately effective.
Track and tend internal quality to report on production yields, complaint trends, production rates and service costs. In order to show continuous improvement, so continued improvement in products can be achieved.
Provides guidance on information infrastructure including hardware and software verification and validation requirements to support performance and quality improvement systems.
Managing the Corrective and Preventive Action (CAPA) system.
Manage the quality assurance function reviewing both internal and external quality of Inogen products. Establish and maintain supplier quality audits, supplier monitoring, standards for verification of received product, and supplier corrective actions.
Participate in product development activities, including evaluating and advising personnel on regulatory impact through product lifecycle stages.
Ensure regulatory standards are understood, and maintain the organizations design control system is in place.
Implement system to capture design validation activities are conducted, and that a Design History File (DHF) is maintained to support regulatory submissions.
Direct incoming inspection activities for any raw material or components of Inogen.
Participate in the transfer of approved product design to Manufacturing to meet market introduction and other key milestone target dates, ensuring that a Device Master Record is in place (specifications, bill of materials, drawings, material specifications, labelling, etc.).
Participate in the development of manufacturing and inspection/ test procedures, including required validations for final product release.
Participate in risk management activities and in the development of risk files for company products to ensure compliance with standards and that output is incorporated into product design.
Participate in change control activities, such as design changes, manufacturing improvements, new supplier introductions, cost reduction initiatives, etc., ensuring that regulatory standards are understood.
Provide mentorship to other Inogen employees and/or Regulatory Affairs staff, as appropriate.
Support key business relationships by providing regulatory expertise specific to contract manufacturing, private label arrangements, due diligence for possible acquisitions, etc.
Provide company-wide Quality Management System (QMS)and Environmental Management System (EMS) training and regulatory expertise, as needed.
Support Lean and Kaizen initiatives to introduce improvements throughout the quality management system.
Support Operations reporting and trending.
Maintain regular and punctual attendance.
Comply with all company policies and procedures.
Assist with any other duties as assigned.
Knowledge, Skills, and Abilities
Capable of compiling data from various sources to produce useful reports and capable of trending and verifying process improvements.
Excellent management skills, both of individuals as well as projects.
Must have strong work ethic.
Excellent oral and written communication skills required.
Attention to detail is required.
Effective conflict resolution.
Analytical & problem-solving skills & ability to multi task.
Solutions-oriented problem solver.
Excellent planning, communication and organizational skills.
Ability to effectively interface with different departments within the company.
In-depth knowledge of FDA , ISO 13485, CMS and MDSAP programs and a track record of successfully implementing and maintaining these programs globally.
Strong project management and organizational skills. Ability to systematically monitor, detect and improve regulatory, quality and compliance programs.
Business acumen – able translate business strategy and objectives into a regulatory/compliance program. Able to show flexibility in approach depending on the business need.
Strong leadership and management skills – track record of building high-performing teams. Can effectively hire talent, retain talent, set expectations, coach and top-grade the organization where appropriate.
Ability to travel up to 30% domestically and internationally.
Qualifications (Experience and Education)
Bachelor’s degree in Engineering, Biological Science or related technical discipline, required.
MBA or advanced degree in management or professional certification in manufacturing disciplines, preferred.
12-15 years' experience in Regulatory Affairs and Quality Assurance for a medical device manufacturing company, required.
2 years’ of experience in at least three of the following areas: product development, manufacturing engineering, quality assurance, materials management, regulatory affairs, product management, required.
6 years management experience, with a minimum of five direct reports, required.
Advanced knowledge/proficiency in Microsoft Office, required.
ASQ CQA and/or ASQ CBA preferred.
Advanced knowledge of ISO 13485 required.
Advanced knowledge of ISO 14971 required.
A combination of training, education and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities
We thank all applicants in advance for their interest in the position. However, only those selected for an interview will be contacted.
Inogen is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally
protected characteristics. The EEO is the Law poster and its supplement are available here: http://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm;
The pay transparency policy is available here: http://www.dol.gov/ofccp/pdf/EO13665_PrescribedNondiscriminationPostingLanguage_JRFQA508c.pdf.
Inogen is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please send an e-mail to email@example.com or call (972) 616-5668 and let us know the nature of your request and your contact information.
- Job Function Management
- Pay Type Salary
- Required Education Bachelor’s Degree
- Richardson, TX, USA