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COMPANY 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.
Skills & Abilities:
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.
OTHER RESPONSIBILITIES
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.
Full Time
Business Services
$81k-103k (estimate)
02/04/2024
05/02/2024
sun-med.com
APOPKA, FL
200 - 500
1981
Private
FREDERIC R KITAIN
$50M - $200M
Business Services