Senior Regulatory Specialist

Globus Medical•Audubon, PA

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. The Senior Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. This position entails development of FDA submissions, requires working knowledge of products under review and of relevant regulations and guidance documents. This individual must be enthusiastic, positive, even-tempered and effective in building working relationships with internal teams while following FDA 21 CFR regulations.

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

Partners with Product Development and management to prepare and review 510(k) submissions
Prepares final 510(k) submissions and obtaining required management approvals
Submits 510(k) documents and responding to the FDA in a timely manner
Assists in the completion of IDE and PMA submissions for IDE clinical trials
Helps to prepare PMA packages, including non-clinical, manufacturing, and clinical sections
Works with personnel in various functional areas to obtain timely submissions to FDA
Obtains and reviews clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for IDE and PMA reporting
Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes
Performs routine maintenance of approved PMAs, including coordination and preparation of PMA supplements, Annual Reports
Trains new staff on relevant Regulatory processes as necessary
Determines Regulatory Pathway for new/changed products under departmental guidelines
Reviews and approve Regulatory Pathway Forms and supporting documentation
Reviews and approves Note-to-File documentation for minor changes to 510(k) cleared products or systems
Understands the company’s products, surgical techniques and the use of implant and instrument systems
Develops relevant Regulatory SOPs as necessary
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