Regulatory Affairs Specialist

AirLife • Grand Rapids, MI

6d

About The Position

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

The specialist serves as a core team member and project representative for Regulatory Affairs on assigned initiatives. The role provides regulatory guidance, supports regulatory strategy and policy, and works with management and cross-functional teams throughout the product lifecycle. Responsibilities span regulatory processes and documentation for product design and development, manufacturing, distribution, and sale, as well as continuous improvement of the Quality System and compliance with current and emerging requirements.

Requirements

• Basic knowledge of medical device regulations, including 21 CFR, FDA regulations, EU MDD/MDR, other global laws and regulations, and standards such as 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.
• 0–2 years of experience in regulatory affairs, specifically within the respiratory and anesthesia sector.
• 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.
• Local travel to complete physical document legalization, as required by business needs.

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 adhering to regulatory compliance.
• Support regulatory policy and strategic planning, and participate in developing, modifying, and executing regulatory strategies and policies that affect AirLife Business Group operations and go-to-market launches.
• Serve as a core member of AirLife teams and as the Regulatory Affairs project representative for assigned initiatives, providing timely regulatory guidance.
• 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 to ensure supporting documentation complies with regulations and standards.
• Interact with management and cross-functional teams to provide regulatory strategy at all stages of a product's lifecycle.
• 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 requirements take effect.
• Advise internal stakeholders, including marketing, manufacturing, and R&D, about current or pending guidance, regulations, and agency or industry initiatives.
• Handle local and physical document legalization for international product registrations, coordinate legalization with outside agencies, and own the legalization process.
• Uphold AirLife's values; work accurately and thoroughly; promote quality and safety; use time and company resources efficiently; contribute to a positive team environment; and follow company policies and guidelines.

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