Posted in Compliance 30+ days ago.
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Type: Full Time
Location: Richardson, Texas
The Regulatory Affairs Manager is responsible for 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.
* Participate in product development activities, including evaluating and advising personnel on regulatory impact through 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 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 change control activities, such as design changes, manufacturing improvements, new supplier introductions, cost reduction initiatives, etc., ensuring that regulatory standards are understood.
* Assist in obtaining regulatory registrations, product clearances/ approvals, certifications and with maintaining documentation needed to support ISO, FDA, and other regulatory compliance, allowing for the sale of Inogen products.
* Support key business relationships by providing regulatory expertise specific to contract manufacturing, private label arrangements, due diligence for possible acquisitions, etc.
* Assist in compiling, submitting, and monitoring reports and responses to regulatory authorities.
* Support regulatory agency inspections and audits.
* Participate in the Internal Audit Program as an internal auditor.
* Support the Supplier Audit Program as an auditor.
* Support the Corrective and Preventive Action (CAPA) Program.
* Support post market surveillance (PMS) activities, including customer complaint handling and regulatory analysis efforts to determine reportability.
* Support the external standards management process by ensuring changes to standards and new standards introduced are understood and integrated into device design proactively.
* Participate in company-wide quality management system training and provide Regulatory expertise.
* 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.
* Limited sign off for Regulatory.
* Lead Corrective and Preventive Action (CAPA) program facilitation efforts.
* Lead international product registration efforts.
Do you possess these abilities*
* Knowledge of ISO, MDD/ MDR and FDA regulations.
* Knowledge of DMEPOS accreditation requirements.
* Knowledge of DMEPOS accreditation requirements.
* Experience with DMEPOS/ CMS.
* Experience in medical device 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).
* Must have strong work ethic.
* Excellent oral and written communication skills are required.
* Attention to detail is required.
* Must demonstrate effective conflict resolution.
* Analytical and problem-solving skills and ability to multitask are required.
* Must be solutions-oriented problem solver.
* Excellent planning, communication and organizational skills are required.
* Ability to effectively interface with different departments within the company is required.
* Bachelor's Degree in a technical discipline required.
* 2-5 years of medical device Regulatory Affairs experience required; 1 year of QMS internal auditing experience required.
* Intermediate knowledge of/ proficiency in Microsoft Office required.
* ISO 13485 (current edition) Lead Auditor Certification and/or ASQ CQA and/or ASQ CBA preferred.
* Intermediate knowledge of ISO 13485 preferred.
* Intermediate knowledge of ISO 14971 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.