About Us:

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:

The Lead Regulatory Affairs Specialist leads the preparation of document packages for regulatory submissions for new and sustaining enhanced technologies, software enabling and robotics systems within the Surgical Intelligence (SI) portfolio, to ensure compliance with local and regional registration requirements. The Lead Specialist will be responsible for coordinating products in alignment with company policies as well as audits and inspections (internal and external), and oversight of global submission requirements, license renewal and annual registration maintenance. The Lead Specialist will be expected to contribute to the registration and maintenance of medical devices of all classifications; able to advise on changes impacting product performance (such as labeling, manufacturing, marketing and clinical development) for regulatory compliance, keeping abreast of regulatory procedures and changes and leading implementation. This role will be instrumental in facilitating strategic interaction with regulatory agencies on defined matters. The Lead Specialist will input to registration strategies for earliest possible approvals of clinical trials applications, as well as market introduction.

Essential Functions:

• Develops and executes regulatory strategies for SI products and ensures the process is documented in compliance with government and company regulations
• Contributes to strategic decisions with expert counsel on regulatory and technical developments considerate of the external environment;
• Authors persuasive and technical submissions including justification of strategies & global Regulatory plans & submissions
• Interfaces with regulatory agencies and certifying bodies for site inspections, presentations, and submissions
• Collaborates with cross-functional departments to ensure required plans demonstrate necessary compliance and consider dynamic regulatory decision making for new and existing products
• Evaluates the regulatory impact of proposed product or process changes, and determines if a new pre-market application is required
• Reviews promotional material and labeling for company marketed products to ensure compliance to pre-market filings
• Provides coaching to junior staff; Anticipates training needs and expert competencies for development
• Performs other duties as assigned
• 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. 

Qualifications:

• 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
• Excellent communication and leadership skills
• Clear understanding of regulatory requirements throughout medical device lifecycle
• Strong understanding of US & EU 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

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. 

Physical Demands:

The physical demands listed here are representative of those that must be met by and 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.

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.

JOB CODE: 1003298