Regulatory Affairs Specialist IV jobs in Richardson

Inogen Inc

Regulatory Affairs Specialist IV jobs are vacant in Richardson,TX. The Inogen Inc it's specialized into Social Services industry. Currently the headquarters are in Texas.

Regulatory Affairs Specialist IV job positions are vacant on Inogen Inc company, located in Richardson with a rate of  $29.25-52.10/hour.

More details about the job listing:

Inogen is focused on quality care continuous improvement and outstanding customer satisfaction. We are a stable USA based company dedicated to providing an exciting and rewarding career to our employees. We completed a successful Initial Public Offering on the NASDAQ in 2014 and have demonstrated substantial growth over the last five years. Our work environment is casual yet high performing and we are looking for seriously talented motivated and fast paced professionals to join our team.

Job Summary:

The Regulatory Affairs position 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.

Responsibilities Specific tasks duties essential functions of the job

* 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.

Regulatory Affairs Level II Regulatory Affairs Specialist

In addition to items listed for Regulatory Affairs Level I Regulatory Affairs Associate Regulatory Affairs Level II Regulatory Affairs Specialist may also be responsible for the following:

* Limited sign off for Regulatory.
* Lead Corrective and Preventive Action CAPA program facilitation efforts.
* Lead international product registration efforts.

Regulatory Affairs Level III Senior Regulatory Affairs Specialist

In addition to items listed for Regulatory Affairs Level II Regulatory Affairs Specialist Regulatory Affairs Level III Senior Regulatory Affairs Specialist may also be responsible for the following:

* Sign off for Regulatory.
* Provide high level of technical expertise to relevant job functions.
* Assist with regulatory agency inspections and audits.

Regulatory Affairs Level IV Regulatory Affairs Principal

In addition to items listed for Regulatory Affairs Level III Senior Regulatory Affairs Specialist Regulatory Affairs Level IV Regulatory Affairs Principal may also be responsible for the following:

* Sign off for Regulatory.
* Lead work of other Regulatory Affairs team members.
* Lead the process of 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.
* Lead regulatory agency inspections and audits.

Knowledge Skills and 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.
* Familarity 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.

Qualifications Experience and Education

Level

Qualifications

Level I

Associate

* Bachelor s Degree in a technical discipline required.
* 0 2 years of medical device Regulatory Affairs 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.

Level II

Specialist

* 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.

Level III

Senior

* Bachelor s Degree in a technical discipline required.
* 5 7 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.
* 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.

Level IV

Principal

* Bachelor s Degree in a technical discipline required.
* 7 10 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.
* 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

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 recruiting inogen.net or call 972 616 5668 and let us know the nature of your request and your contact information.

Other details

* Job Family Regulatory Affairs Specialist
* Job Function Individual Contributor
* Pay Type Salary
* Required Education Bachelor s Degree

Apply Now

* Richardson TX USA

To apply for this job email your details to office@martekmediamarketing.com

Job Overview
Job Location