Regulatory Affairs Specialist

AirLife Regulatory Affairs Specialist

At AirLife, we are dedicated to improving the quality of every breath. Excellence with Every Breath is not just a tag line, but the way we work and take care of our customers. With a mindset to evolve, innovate, and grow, we are a premier manufacturer of the highest-quality and market-leading breathing consumables. This growth philosophy has positioned us to increase our global footprint and business reach, impacting even more people around the world. Our expanding family of the most trusted brands offers a product portfolio that spans the continuum of care from first responder to home care, with safety, patient comfort, and clinical performance in mind. Collective expertise allows us to provide quality products and experiences to our patients, customers, and our people. Our values of Customer First, Differentiate with Our People, Bias for Action, Continuous Improvement, and Accountability define who we are and how we work. Join us!

The Regulatory Affairs Specialist supports the preparation and maintenance of regulatory submissions, product registrations, and quality system documentation to ensure compliance with global medical device regulations. This includes documentation legalization for the support of international product registrations handled locally/physically and the coordination of document legalization with outside agencies and the ownership of the legalization process. This entry-level role provides administrative and technical assistance to the Regulatory Affairs Systems team.

Position Qualifications

Knowledge, Skills, & Abilities:

• Basic knowledge of medical device regulations (21CFR), FDA regulations, EU MDD/MDR, other global laws and regulations and standards including ISO 14971, ISO 13485/MDSAP and related particular standards.
• Strong organizational skills and attention to detail.
• Effective written and verbal communication skills.
• Ability to manage multiple priorities and deadlines.
• Proficient computer skills in Microsoft Office.
• Experience with project deliverables and timelines for global regulatory submissions, preferred.

Level of Experience:

• 0–2 years of experience in regulatory affairs, specifically within the respiratory and anesthesia sector.

Level of Education:

• Bachelor’s degree preferably in Regulatory Affairs and/or an engineering or science related field or equivalent experience in the medical device and/or pharmaceutical industry.

Travel:

As the business needs. Local travel to complete physical document legalization required.

Essential Duties and Responsibilities

• Assist in preparation of regulatory submissions and product registrations.
• Maintain regulatory files and databases.
• Support change control and quality system documentation.
• Provide administrative support during audits and inspections.
• Increase collaboration to address customer quality and delivery along with adherence to regulatory compliance.
• Formulate and provide support for regulatory policy into a regulatory strategic plan, while also being involved in developing, modifying, and executing company regulatory strategies and policies that affect immediate AirLife Business Group operations supporting go-to-market launches and activities.
• Responsible as a core member and lead on the AirLife teams, along with the project representative for Regulatory Affairs on assigned initiatives, the Regulatory Affairs Specialist will provide timely and valued regulatory guidance by owning the following tasks:
• Defining and implementing the key processes that are the responsibility of the Regulatory Affairs department that includes specific inputs and outputs for the design & development, manufacturing, distribution and sale of AirLife products.
• Standardizing, deploying and implementation of regulatory information to ensure that supporting documentation is compliant with regulations & standards.
• Regular interaction with management and cross-functional teams to provide regulatory strategy at all stages of a product’s lifecycle.
• Driving improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System.
• Ensuring compliance with the current regulatory procedures and updating the procedures when new regulatory requirements become effective.
• Advising internal stakeholders (marketing, manufacturing, R&D, etc) regarding current/pending guidance, regulations, Agency/industry initiatives, etc to ensure regulatory strategy is aligned with company objectives.

Other Responsibilities

• Uphold and embody AirLife’s values in all aspects of work.
• Demonstrate accuracy and thoroughness in daily work; look for ways to improve and promote quality & safety.
• Inspire the trust of others; treat people with respect and dignity and embrace the value of diversity.
• Use time efficiently; perform job accurately, thoroughly, and conserve Company resources to improve profits.
• Contribute to building and maintaining a positive team environment.
• Assure all policies and guidelines are implemented and followed.

Quality Policy

At AirLife, Quality is our promise. It is our commitment to customer satisfaction and our dedication to product excellence in an evolving global healthcare market. This promise is kept through a continuously improving and effective Quality Management System and compliance to Regulatory Requirements.

DEIA Statement

At AirLife, we are committed to building a diverse workforce and an inclusive workplace that reflects the communities and customers we serve. We believe our philosophy on Diversity, Equity, Inclusion, and Advancement (DEIA) encourages excellence and equips us to serve an evolving global marketplace.

Benefits

AirLife offers a comprehensive benefits package, including medical, dental, and vision coverage, 401(k), paid time off, paid holidays, bereavement leave, Employee Assistance Program resources, and medical leave benefits, subject to applicable eligibility requirements. Certain positions may also be eligible for bonus, commission, or other incentive compensation.

Please note: The responsibilities outlined above are not exhaustive and may evolve over time. The role holder may be required to undertake additional duties as reasonably expected to meet the needs of the company.