Regulatory Affairs Specialist

AirLife • Grand Rapids, MI

1d

About The Position

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

The Specialist contributes regulatory guidance and strategy across product lifecycles and assigned initiatives, working with management and cross-functional teams. The position supports AirLife’s go-to-market launches and activities, regulatory processes, documentation, and continuous improvement of the Quality System. Local travel is required to complete physical document legalization; other travel is based on business needs.

Requirements

• Basic knowledge of medical device regulations, including 21 CFR and 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.
• Proficiency with Microsoft Office.
• Bachelor’s degree, preferably in Regulatory Affairs or an engineering- or science-related field, or equivalent experience in the medical device and/or pharmaceutical industry.
• 0–2 years of experience in regulatory affairs, specifically within the respiratory and anesthesia sector.

Nice To Haves

• Experience with project deliverables and timelines for global regulatory submissions.

Responsibilities

• Assist in preparing regulatory submissions and product registrations.
• Maintain regulatory files and databases.
• Support change control and quality system documentation.
• Provide administrative support during audits and inspections.
• Collaborate to address customer quality and delivery while maintaining regulatory compliance.
• Support regulatory policy and strategic planning, including company regulatory strategies and policies affecting AirLife Business Group operations and go-to-market launches.
• Define and implement Regulatory Affairs processes, including inputs and outputs for product design and development, manufacturing, distribution, and sale.
• Standardize, deploy, and implement regulatory information so supporting documentation complies with regulations and standards.
• Interact with management and cross-functional teams to provide regulatory strategy throughout product lifecycles.
• Drive improvement in regulatory aspects of the Quality System, develop processes, and document procedures to support an effective Quality System.
• Ensure compliance with current regulatory procedures and update procedures when new regulatory requirements take effect.
• Advise internal stakeholders, including marketing, manufacturing, and R&D, about current and pending guidance, regulations, and agency or industry initiatives.
• Handle local, physical document legalization for international product registrations, coordinate legalization with outside agencies, and own the legalization process.
• Uphold AirLife’s values, contribute to a positive team environment, follow policies and guidelines, and perform work accurately and efficiently.

Benefits

• Medical coverage
• Dental coverage
• Vision coverage
• 401(k)
• Paid time off
• Paid holidays
• Bereavement leave
• Employee Assistance Program resources
• Medical leave benefits
• Certain positions may be eligible for bonus, commission, or other incentive compensation.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level