Associate Regulatory Affairs - Globus Medical, Inc.
Audubon, PA
About the Job
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 Regulatory Affairs Associate assists in drafting, submitting and gaining 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, requiring 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.
Essential Functions:
+ Partnering with Product Development and management to prepare and review 510(k) submissions
+ Preparing final 510(k) submissions and obtaining required management approvals
+ Submitting 510(k) documents and responding to the FDA in a timely manner
+ Assisting in the completion of IDE submissions for IDE clinical trials
+ Helping to prepare PMA packages, including non-clinical, manufacturing, and clinical sections
+ Working with personnel in various functional areas to obtain timely submissions to FDA
+ Obtaining and reviewing clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for IDE and PMA reporting
+ Reviewing Document Change Orders for Regulatory compliance, including drawings and labeling changes
+ Performing routine maintenance of approved PMAs, including coordination and preparation of PMA supplements, Annual Reports
+ Assisting in Regulatory Pathway Form determinations under departmental guidelines
+ Administrative tasks, such as filing, scanning, organizing file, as needed. Reviewing and filing Note-to-File documentation for minor changes to 510(k) cleared products or systems
+ Understanding the company’s products, surgical techniques and the use of implant and instrument systems
+ Adhering to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
+ Ensure 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
+ Representing 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
_R_ _easonable accommodations may be made to enable individuals with disabilities to perform these_ _essential_ _functions._
Qualifications:
+ Bachelor’s degree in health or science-related field, or equivalent; Engineering degree is a plus
+ Knowledge of US Code of Federal Regulations Title 21
+ Minimum of 0-2 years’ experience in medical device industry or equivalent, preferably within orthopedic medical devices; Regulatory Affairs experience is a plus
+ Excellent communication and listening skills
+ Proficient with Microsoft Office, including Word, Excel, PowerPoint and Teams
+ Strong time management skills, with the ability to work on multiple projects simultaneously
+ Able to work independently as well as within a team
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.
Position Summary:
The Regulatory Affairs Associate assists in drafting, submitting and gaining 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, requiring 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.
Essential Functions:
+ Partnering with Product Development and management to prepare and review 510(k) submissions
+ Preparing final 510(k) submissions and obtaining required management approvals
+ Submitting 510(k) documents and responding to the FDA in a timely manner
+ Assisting in the completion of IDE submissions for IDE clinical trials
+ Helping to prepare PMA packages, including non-clinical, manufacturing, and clinical sections
+ Working with personnel in various functional areas to obtain timely submissions to FDA
+ Obtaining and reviewing clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for IDE and PMA reporting
+ Reviewing Document Change Orders for Regulatory compliance, including drawings and labeling changes
+ Performing routine maintenance of approved PMAs, including coordination and preparation of PMA supplements, Annual Reports
+ Assisting in Regulatory Pathway Form determinations under departmental guidelines
+ Administrative tasks, such as filing, scanning, organizing file, as needed. Reviewing and filing Note-to-File documentation for minor changes to 510(k) cleared products or systems
+ Understanding the company’s products, surgical techniques and the use of implant and instrument systems
+ Adhering to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
+ Ensure 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
+ Representing 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
_R_ _easonable accommodations may be made to enable individuals with disabilities to perform these_ _essential_ _functions._
Qualifications:
+ Bachelor’s degree in health or science-related field, or equivalent; Engineering degree is a plus
+ Knowledge of US Code of Federal Regulations Title 21
+ Minimum of 0-2 years’ experience in medical device industry or equivalent, preferably within orthopedic medical devices; Regulatory Affairs experience is a plus
+ Excellent communication and listening skills
+ Proficient with Microsoft Office, including Word, Excel, PowerPoint and Teams
+ Strong time management skills, with the ability to work on multiple projects simultaneously
+ Able to work independently as well as within a team
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.
Source : Globus Medical, Inc.