Posted in Compliance 29 days ago.
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Type: Full Time
Location: Richardson, Texas
The Regulatory Affairs Specialist has responsibility for ensuring organizational compliance with quality and regulatory standards for both product and company operations. The position is responsible for supporting the Quality Management System and for ensuring product design efforts are in step with business objectives and applicable government directives.
* Assist in compiling, submitting, and monitoring reports and responses to regulatory authorities.
* Support regulatory agency inspections and external audits.
* Support Operations reporting and trending.
* Support the Internal Audit Program as an internal auditor.
* Support the Supplier Auditor Program as a supplier auditor, as required.
* Provide support in company-wide Quality Management System training activities and provide regulatory expertise, as needed.
* Support the Corrective and Preventive Action (CAPA) Program.
* Support Kaizen initiatives to introduce improvements throughout the Quality Management System (QMS), as Regulatory Affairs department representative.
* Participate in product development activities, including evaluating and advising personnel on regulatory impact throughout product lifecycle stages, ensuring that regulatory standards are understood, that a design control system is in place, that design validation activities are conducted, and that a Design History File (DHF) is maintained to support regulatory submissions.
* Participate in 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, labeling, etc.).
* Participate in the development of manufacturing and inspection/ test procedures, including required validations for final product release.
* Participate in change control activities, such as design changes, manufacturing improvements, new supplier introductions, cost reduction initiatives, etc., ensuring that regulatory standards are understood.
* Support the external standards management process by ensuring changes to standards and new standards introduced are understood and integrated into device design proactively.
* Support post market surveillance (PMS) activities, including customer complaints/ adverse medical event reporting systems, clinical evaluation reports, etc.
* Support key business relationships by providing regulatory expertise specific to contract manufacturing, private labeling arrangements, etc.
* Assist in obtaining all necessary domestic regulatory registrations, product clearances/ approvals, certifications and in maintaining documentation needed to support ISO, FDA, compliance, allowing for the sale of Inogen products in US, as determined by business objectives, as assigned.
* Provide support to the Environmental Management System (ISO 14001).
* Maintain regular and punctual attendance.
* Comply with all company policies and procedures.
* Assist with any other duties as assigned.
Do you possess these abilities*
* Knowledge of ISO 13485, ISO 14971 and FDA regulations.
* Knowledge of DMEPOS accreditation requirements.
* Experience with DMEPOS/CMS.
* Knowledge of ISO 14001.
* Experience in Regulatory Affairs and at least one (1) of the following: product development, manufacturing engineering, quality assurance, or production management.
* Ability to support external/ internal audits.
* Attention to detail and process improvement capabilities.
* Excellent skills with database systems and Excel with capability to compile data from various sources to produce useful reports for trending and verifying process improvements.
* Familiarity with process improvement concepts (i.e. LEAN Six Sigma).
* Able to execute at a task + project level independently, able to make decisions independently, and sign-off on in most instances on behalf of Regulatory/QMS function.
* Minimal supervision required.
* Able to provide Regulatory/QMS support on wide array of Regulatory/QMS related topics.
* May be able to mentor/train junior staff members.
* May supervise/manage direct reports, as assigned.
* Able to lead 3rd party audits and represent Inogen during these audits.
* Bachelor's in a Technical Discipline, required.
* Master's in Technical Discipline, preferred.
* 5-7 years of experience, including 3-5 years' experience with class II medical devices, required.
* ISO 13485:2016 Lead Auditor Certification and/or ASQ CQA, and/or ASQ CBA, required.
* Knowledge of US medical device regulatory requirements.
* Regulatory Affairs Certificate (RAC), preferred.
* A combination of training, education and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.
WHY INOGEN Inogen is a dynamic company that is not only focused on quality care of patients, but is also committed to being a top employer. Each of Inogen' s offices have a casual culture that supports employees being responsible and developing professionals.
We offer competitive salaries and a robust benefit package:
* Employee Stock Purchase Plan 401 (K) plan available for all employees Health, dental, vision insurance Flexible spending accounts and wellness discount program Life Insurance Long Term Disability Robust paid time off and 8 paid holidays Employee Assistance Program
See the Inogen Team in action:
Inogen Where we go to work hard to positively impact people\'s lives
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; http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf. 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 firstname.lastname@example.org or call (972) 616-5668 and let us know the nature of your request and your contact information.