Job Description:

Regulatory Affairs Project Manager

Inogen, Inc., 301 Coromar Drive, Goleta, California, United States of America
Req #533

Tuesday, September 14, 2021

ABOUT INOGENInogen was founded in 2001 to improve quality of life and increase freedom and independence for oxygen therapy users. Inogen is innovation in oxygen therapy. The Inogen mission is to improve freedom and independence for oxygen therapy patients through innovative products and services. Inogen is a manufacturer and Accredited Homecare Provider.

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 RA Project Manager is responsible for managing Inogen's regulatory affairs projects. This position coordinates cross-functional resources and schedules to deliver project plans and deliverables on-time, within budget, and in alignment with company-wide priorities. The RA Project Manager will work closely with the regulatory affairs, quality assurance, commercial, portfolio, and design engineers to ensure that projects are thoroughly planned and documented to ensure that regulatory standards, international registrations, and design control activities are planned proactively and executed to ensure compliance and adherence to best practices in the medical device industry.

Responsibilities (Specific tasks, duties, essential functions of the job)

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  Manage assessment, tracking, and implementation of applicable RA standards and practices.
  
  


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  Collaborate with product management and engineering to manage product portfolio life cycle planning to ensure that products are compliant with regulatory standards as they are updated, published, and adopted.
  
  


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  Manage project timelines, resources, milestones, and budget costs, with appropriate project status reporting to management, as applicable.
  
  


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  Conduct meetings and track project status to set goals, monitor timelines, align expectations, facilitate cross-functional communication, and ensure task completion.
  
  


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  Coordinate activities, including market release activities according to product plans and international roll-out strategies including registration/clearance activities and reimbursement.
  
  


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  Effectively communicate and collaborate with Product Management, Regulatory Affairs, Medical Affairs Quality Affairs, and Operations, to define project requirements, make decisions, and accomplish objectives.
  
  


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  Promote teamwork and motivate others to solve challenges in a productive and positive manner.
  
  


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  Manage projects of varying size and complexity from conception to completion per internal procedures and regulatory standards for new products, product lifecycle management, and global commercialization plans.
  
  


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  Maintain regular and punctual attendance.
  


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  Comply with all company policies and procedures.
  


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  Assist with any other duties as assigned.
  

Knowledge, Skills, and Abilities

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  Must have strong work ethic.
  


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  Analytical & problem-solving skills & ability to multi task.
  


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  Solutions-oriented problem solver.
  


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  Excellent planning, communication, and organizational skills.
  


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  Strong background in Project Management best practices, preferably according to PMI processes.
  


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  Excellent oral and written communication skills as well as excellent presentation skills with ability to conduct presentations comfortably to large groups.
  


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  Demonstrated capability for planning, decision making, and conflict resolution.
  


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  Proven leadership ability with an emphasis on accountability communication.
  


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  Strong relationship building and interpersonal skills.
  


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  Strong understanding of FDA/ISO Design Control requirements required.
  


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  Attention to detail and follow through required.
  


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  Passion for product quality and excellence required.
  


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  Strong technical writing and organizational skills required.
  


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  Ability to multitask in a fast-paced team environment required.
  

Qualifications (Experience and Education)

• Bachelors' degree required. Scientific or health related field, preferred.


• 5 years' experience in regulatory project management experience, required


• Project management certification from PMI or equivalent, preferred.


• Fluent in MS Project, Excel and other MS Office applications, required.


• Advanced knowledge/proficiency ISO 13485, MDD or MDR required.


• Advanced knowledge in FDA GMP and ISO regulated quality systems, required.


• Knowledge of global regulatory landscape 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.

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: https://www.dol.gov/agencies/ofccp/faqs/pay-transparency

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.netor call (972) 616-5668 and let us know the nature of your request and your contact information.

Other details

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  Job Function
  Individual Contributor
  
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  Pay Type
  Salary
  
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  Required Education
  Bachelor's Degree
  

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  Inogen, Inc., 301 Coromar Drive, Goleta, California, United States of America

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