Regulatory Affairs Manager

Advanced Respiratory Technologies, Inc. is a medical device company located outside of Pittsburgh, PA that is developing a transformative artificial lung system for the treatment of chronic lung diseases. Our primary goals are: (1) to produce a means of permanent respiratory support for the hundreds of thousands of chronic lung disease patients who will not be able to receive a lung transplant and die each year and (2) Further develop our system to be utilized in treating and evacuating wounded soldiers from far-forward positions in close proximity to the battlefield to definitive care in the United States. Our company values and fosters a team based approach to accomplish these goals to transform the treatment of lung disease patients.

We are seeking a highly motivated and talented individual to join our team as an Regulatory Affairs Manager. As a key member of our Medical Devices team, you will be responsible for developing and implementing regulatory strategies for our company's medical devices; leading the design and implementation 21 CFR 820 Quality Systems; developing and implementing regulatory strategies for our company's medical devices; performing risk analysis studies; authoring and submitting regulatory filings to the FDA, including 510k applications; and interfacing with regulatory consultants who will aid in the implementation of all of the above directives. In this position, you will collaborate with cross-functional teams to execute and deliver innovative engineering solutions that could help improve the respiratory health of people worldwide.

The ideal candidate has a passion for innovation, is detailed-oriented, and proactive in their approach.

Responsibilities

• Design and develop medical devices from concept through production release while adhering to design input requirements, project timelines, and quality standards.
• Interface with technicians to manufacture prototype medical devices
• Improve manufacturing processes.
• Conduct design analysis, modeling, and simulation to optimize device design and performance.
• Perform in vitro testing and analyze collected data
• Collaborate with cross-functional teams (e.g., product, manufacturing, quality, regulatory, clinical partners) throughout the product development process.
• Lead the preparation of technical reports, design history files, and regulatory filings for medical device submissions.
• Participate in design reviews, risk assessments, and post-market surveillance activities.

Typical workweeks are 37.5 hours with some increases in working hours as project timelines dictate. This position has the flexibility for either hybrid or fully on-site work at our 1105 William Pitt Way, PIttsburgh, PA 15238 location. (Harmar Township)

Initial interviews will be conducted via telephone or video formats.

Requirements

• Bachelor's degree or Master's degree in Regulatory Science or a related degree.
• 5+ years of prior regulatory affairs experience in the medical device field.
• High proficiency in preparing and filing successful 510k submissions
• Strong understanding of FDA Quality System requirements for Class II and Class III medical devices
• Excellent communication skills and ability to work in a team environment.
• Willing to work either hybrid or fully on-site at our location in Harmar Township, (outside of Pittsburgh, PA)
• Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa.

Benefits

Benefits to working at Advanced Respiratory Technologies, Inc.

• Be part of a growing team and medical device company that is developing new technologies that could each year treat hundreds of thousands of patients who have chronic lung diseases.
• A benefits package that includes:
  • Medical, Prescription Drug, Dental, and Vision plan packages
  • Company Retirement contributions
  • Paid Time Off
• Competitive Salary - $132,000-$142,000
• Flexible start time between 7 am and 9 am
• Hybrid work option

When applying through workable you will be prompted with an optional survey to collect demographic data and for self-identification as a protected veteran and/or as an individual with disabilities.

Advanced Respiratory Technologies, Inc. is a Drug-Free Workplace.

Advanced Respiratory Technologies, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, age, marital status, family status, pregnancy, disease, genetic information, relationship to a person with a disability, and other categories protected by federal, state, or local law.

EEO is the Law

Applicants and employees are protected under Federal law from discrimination. To learn more, use the links below:

https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

https://www.eeoc.gov/poster

Pay Transparency Non-Discrimination Provision

Advanced Respiratory Technologies, Inc. follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, use the link below:

https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf