Globusmedical

Globusmedical

International Regulatory Specialist

Audubon, PA

No sponsorshipDetected 6 days ago
Patient CareFDA RegulatoryMedical Devices

About the role

  • The International Regulatory Specialist will be responsible for drafting, submitting, and gaining approval of product registrations and other submissions to international regulatory agencies.
  • Obtain timely marketing clearance for all products in parallel with US submissions;
  • Provide regulatory oversight of changes in manufacturing facilities, processes, and procedures, as they pertain to international regulations;

Requirements

  • Requires a Bachelor's degree or foreign equivalent in engineering or a relevant scientific field (Biology, Chemistry, Physics, Pharmacy, etc.) or related field;
  • 5 years of experience in a related occupation;
  • Experience ensuring compliance with U.S. FDA and international regulatory requirements;
  • Experience evaluating proposed product and process changes to determine their impact on regulatory status across U.S. and global markets;
  • Experience researching and analyzing regulatory requirements;
  • Experience offering regulatory feedback for various transfer and remediation projects;
  • Experience coordinating and contributing to the preparation and submission of Technical Documentation for EU MDR submissions, including significant change notifications;
  • Experience performing detailed regulatory gap assessments to identify compliance deficiencies and recommending corrective actions in line with current industry and regulatory standards
  • Experience preparing key regulatory deliverables, including Letters to File (LTF), Regulatory Release Memos, and Regulatory Analyses for FDA 510(k)-cleared products.
  • Experience providing expert regulatory guidance to development project teams, contributing to the formulation of comprehensive regulatory strategies for innovative medical devices and new product introductions
  • Our Values:
  • Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.
  • Passionate about Innovation: Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions.
  • Customer Focused: We listen to our customers' needs and respond with a sense of urgency.

Benefits

  • At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders.
  • Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them.
  • Globus Medical is an
  • All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship.

Company info

  • Improving patient care by delivering advanced technology to our customers is at the core of what we do.
  • We are passionate in our role in improving the lives of patients by continuously developing better solutions.
  • We listen to our customers' needs and respond with a sense of urgency.
  • We are accountable to one another and support each other.
  • We pursue our mission with energy and passion.
  • We are nimble, results-oriented and decisive.
  • We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.

Equal opportunity

  • Globus Medical is an equal opportunity employer.
  • We are committed to a diverse workforce.
  • We value all employees' talents and support an environment that is inclusive and respectful.
  • Other Duties:

Visa & Work Authorization

  • rd to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship
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This listing is sourced directly from Globusmedical's careers page and normalized into a canonical job model.