Sr Regulatory Affairs Specialist

Globus Medical•Audubon, PA

12d

About The Position

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. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible. Position Summary : Coordinates and prepares document packages for regulatory submissions for new and mature products, ensuring compliance with local and regional registration requirements. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking and control systems. Keeps abreast of regulatory procedures and changes. Recommends strategies for earliest possible approvals of clinical trials applications.

Requirements

Typically requires a minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work experience
5+ years of related experience in the medical device industry
Understanding of regulatory requirements throughout the product lifecycle
Solid understanding of regulatory terminology, pre-market submission types, and requirements
Able to evaluate regulatory impact of proposed product and process changes
Capable multi-tasking skills with the ability to project plan and meet deadlines
Result driven with a sense of responsibility, urgency and ability to perform under pressure

Responsibilities

Determines the appropriate regulatory strategy for new products and documents all related activates to remain in compliance
Demonstrates global regulatory expertise in product submissions and evaluates changes with local regulations
Collaborates with various departments to review the required plans, procedures and regulatory decisions for new or existing products
Reviews regulatory requirements from other departments for new product designs or changes to existing designs
Reviews technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry
Prepares and maintains regulatory pre-market submissions and other pre-market filings to assist in acquiring appropriate commercial distribution clearances
Supports product import by providing applicable regulatory documentation and certificates
Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.
Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.