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:

Reviews the preparation of document packages for regulatory submissions to ensure compliance with local and regional registration requirements. Coordinates products in alignment with company policies as well as internal audits and inspections. Oversees all materials required in submissions, license renewal and annual registrations. Drives changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Keeps abreast of regulatory procedures and changes. Leads interaction with regulatory agencies on defined matters. Facilitates strategies for earliest possible approvals of clinical trials applications.

Essential Functions:

Drives regulatory strategies for new products and ensures the process is documented in compliance with government and company regulations

Interfaces with regulatory agencies and certifying bodies for site inspections, presentations, and submissions

Collaborates with various departments to review the required plans, procedures and regulatory decisions for new or existing products

Evaluates the regulatory impact of proposed product or process changes, and determines if a new pre-market application is required

Influences business decisions with counsel on regulatory and technical developments in the industry

Reviews promotional material and labeling for company marketed products to ensure compliance to pre-market filings

Controls and maintains all company regulatory records

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. 

Qualifications:

Clear understanding of regulatory requirements throughout the product lifecycle

Strong understanding of regulatory terminology, pre-market submission types, and requirements

Demonstrated ability to evaluate regulatory impact of proposed product and process changes

Advanced multi-tasking skills with the ability to project plan and meet deadlines

Very result driven with a strong sense of responsibility, urgency and ability to perform under pressure

Typically requires a minimum of 8 years of related experience with a Bachelor’s degree; or 6 years and a Master’s degree; or a PhD with 3 years experience; or equivalent experience

12+ years of related experience in the medical device industry

Physical Demands:

The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Required to sit; climb or balance; and stoop, kneel, crouch or crawl

Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds

Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus

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.

Teamwork: Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.

Driven: 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 Employment Opportunity:

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

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.