AddressCOMPANY DESCRIPTION
At AirLife, we are dedicated to improving the quality of every breath. Excellence with Every Breath is not just a tagline, 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!
POSITION SUMMARY
The Sr. Global Regulatory Specialist is responsible for establishing and sustaining the global device registrations and licenses for the organization. This position will partner with the International Sales team to service customer needs.
The Sr. Global Regulatory Specialist will support our efforts to ensure compliance with global market requirements. This position will be responsible for gathering and establishing documentation relevant to international registrations and licenses and daily business needs. This includes, but is not limited to, MDSAP (Canada, Brazil, Australia, and Japan) and EU requirements.
Another responsibility of this role is to represent the Regulatory Affairs department in corporate projects. They will perform regulatory impact assessments and support the deliverables from those assessments.
POSITION QUALIFICATIONS
The specific minimum competencies needed to perform the essential duties of the job include knowledge, skills, abilities, level of education, and experience necessary for successful performance. These competencies are generally demonstrated through specific service, education, or training.
Knowledge:
Acquired through education, certifications, training, and experience.
- Work in an FDA-regulated industry.
- Experience with product requirements, US, Canada, EU and other major international markets.
- Knowledge of quality and product standards for medical devices (e.g. ISO 13485, ISO 14971, FDA QSR, EU MDD/MDR, and Canadian MDR)
Skills & Abilities:
- Excellent technical writing skills.
- Excellent verbal and written communication skills.
- Excellent organizational skills and attention to detail.
- Ability to multitask.
- Strong adaptability and active learning to keep pace with evolving International regulatory needs.
- Excellent time management.
- Strong computer skills: MS Word, MS Excel (chart, pivot tables), PowerPoint, and database management.
- Attention to detail
- Analytical skills
Level of Experience: 5 years of experience in medical device or equivalent. 5 years of experience in regulatory affairs or equivalent
Level of Education: Bachelor’s degree in Biological Sciences, Biochemistry, Chemistry, Toxicology, Pharmacy, Medicine, Engineering, or another similarly technical field.
Travel: 10%
ESSENTIAL DUTIES AND RESPONSIBILITIES
The core tasks, duties, and responsibilities that must be performed on the job.
- The International Regulatory Specialist is responsible for establishing and maintaining our global registrations and licenses.
- Organize and track Airlife’s existing global registrations.
- Work closely with the International Sales team to grow our global footprint.
- Coordinate efforts associated with the preparation of regulatory documents and submissions for international registrations.
- Develop and conduct regulatory training related to international requirements.
- Communicate with foreign distributors and regulatory agencies regarding pre-submission strategies, potential regulatory pathways, or clarification and follow-up of submissions under review.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Participate in internal and external audits as it relates to global registrations, licensing, and requirements.
- Recommend updates to technical documentation and associated procedures in response to changes in international regulations or standards.
OTHER RESPONSIBILITIES
- Focus on achieving our Company mission.
- 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.
