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Senior Regulatory Affairs Specialist

Pittsburgh, PA
We’re working on behalf of a global medical technology company built on decades of experience and a relentless commitment to improve the lives of patients around the world.  The company is a worldwide leader that is dedicated to creating meaningful products and therapies that transform lives each and every day.  The company offers a diverse product portfolio with a differentiated pipeline.  Their global reach is broad with a presence in more than 100 countries and approximately 4,000 employees.  The company is a global leader in cardiovascular solutions with an established leadership position in heart-lung machines and recognition as the world’s #1 cardiopulmonary bypass company. And their neuromodulation expertise allows them continue to advance medical device solutions for people affected by drug-resistant epilepsy and treatment-resistant depression.
 
Looking for an opportunity with a leader?  We seek candidates with expert knowledge and understanding of global regulations relevant to Class III and/or Class III medical devices for the role of Senior Regulatory Affairs Specialist.  The person in this role will develop and implement global regulatory strategies designed to reduce product development cost/time and achieve faster-than-average review times with regulatory bodies. He/she will review and approve protocols, reports, engineering drawings, procedures, labeling and other product development and manufacturing documentation to ensure compliance with regulatory requirements, consistency and accuracy. He/she will provide direction and guidance to project teams to execute tactical regulatory affairs projects and/or initiatives.  Includes preparation and oversight of larger documentation packages for submission to regulatory agencies. He/she will track timelines and documents for inclusion in regulatory submissions.  He/she will interact with regulatory agencies as part of submission review and on-site audit support.
 
Candidates should have a Bachelors degree, and a scientific discipline is required.  Candidates should have a 5-7 years previous related experience. Must have expert knowledge and understanding of global regulations relevant to Class III and/or Class III medical devices.  Must be able to work independently.
 
The role offers highly competitive compensation and benefits.  This is an excellent opportunity to work and thrive in an environment where transformational change happens within hours and days. For more information call 941.739.1400 or submit your resume now by clicking on the button below that says “Apply Now.”
 
Eric Boelkins
Edge Recruitment Solutions
888.666.2450 or 941.739.1400
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