Gentell is one of the largest vertically integrated wound care companies in the world. Based in Yardley, PA and with offices, distribution centers and manufacturing plants around the world, our purpose is to make a positive difference in the quality of life for the injured, the chronically ill and those near the end of life. Our success is a result of the talents, dedication and commitment of our people to drive our business forward. We provide career advancement opportunities through Gentell University, leadership development programs and executive mentoring. You would be joining a company committed to “make it better” every day, for our customers and for our employees. The Regulatory Affairs Specialist will be assisting international medical device registrations, regulatory submissions and compliance activities across multiple regions. The ideal candidate will have hands-on experience with global regulatory bodies such as ANVISA, MHRA, EU MDR, Health Canada, and FDA. The specialist will ensure products meet global regulatory compliance requirements, review technical documentation, and stay updated with evolving regulatory requirements. This role will also involve reviewing product labeling and supporting audits. Key Responsibilities: · Prepare and compile regulatory dossiers to various health authorities (e.g., FDA, EU MDR, Health Canada, ANVISA) for new products and product changes. · Prepare, compile, and submit FDA 510(k) premarket notifications for Class II medical devices. · Develop and maintain Technical Documentation per EU MDR (2017/745) for CE / UKCA marking. · Ensure that regulatory submissions meet the requirements of regional health authorities, including ISO, MDSAP, and other relevant standards. · Maintain familiarity with international regulatory requirements and guidelines to ensure product compliance. · Support post-market surveillance activities, including vigilance and reporting requirements. · Assist with Ad hoc requests for various regulatory documents in support of registration activities/tenders. · Liaise with cross-functional teams including R&D, Quality Assurance, and marketing to ensure regulatory compliance. · Review and approve product labeling and artwork to ensure compliance with regional regulatory standards. · Conduct gap assessments between current company standards and updated regulatory requirements. · Assist with change control processes, ensuring regulatory compliance when implementing changes to products or processes. · Collaborate with international manufacturing and quality assurance teams to evaluate the impact of changes on regulatory submissions. · Assist with documentation management, ensuring all regulatory records are maintained and readily available for audits or inspections. Required Qualifications: Bachelor’s degree in life sciences, regulatory affairs, or a related field. 3-5 years of experience in a similar role. Proven experience with MDR technical documentation authorization. Proven experience preparing and submitting 510(k) applications. Familiarity with change control processes and post-approval changes. Ability to work within a team and as an individual contributor in a fast-paced environment and manage competing priorities. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization; Ability to work independently and manage multiple projects simultaneously. Strong organizational and follow-up skills, as well as attention to detail. Preferred Qualifications: · Experience with Class I,II and III medical devices classifications. · Prior experience in 510K submissions. · Knowledge of ISO 13485, ISO 14971, and other relevant standards. · Experience in conducting regulatory gap assessments. · Proficiency in regulatory software and systems for document control and submissions. · Certification in Regulatory Affairs (RAC) is a plus.

Gentell is one of the largest vertically integrated wound care companies in the world. Based in Yardley, PA and with offices, distribution centers and manufacturing plants around the world, our purpose is to make a positive difference in the quality of life for the injured, the chronically ill and those near the end of life. Our success is a result of the talents, dedication and commitment of our people to drive our business forward. We provide career advancement opportunities through Gentell University, leadership development programs and executive mentoring. You would be joining a company committed to “make it better” every day, for our customers and for our employees. We are seeking a team member to collect signatures on physicians’ orders for durable medical equipment provided to long term care residents . This position is responsible for handling physicians’ orders for designated doctors, medical offices and/or nursing homes. This position is responsible for creating and maintaining strong relationships with physicians, nursing home staff, and Gentell field representatives; therefore, customer service skills are a must. Responsibilities: Track and collect Certificates of Medical Necessity (CMNs) (80% of the time). Develop efficiencies in departmental processes to maximize timely return of physicians’ orders. Responsible for special handling of designated accounts. Responsible for collecting signatures on physicians' orders in the assigned territory Perform other duties as assigned. Preferred Knowledge, Skills, and Abilities: Excellent verbal and written communication and customer service skills. Persistent and results oriented. Driven to win, both working independently and as a part of the team. Strong organization skills and attention to details. Strong work ethic. Ability to follow through to resolve outstanding issues. Ability to work with a sense of urgency and a high level of responsiveness. Ability to maintain confidentiality and exercise extreme discretion. Proficiency in using Microsoft Office and Adobe Acrobat.

As a member of our team at Gentell, your role will involve collecting signatures on physicians" orders for durable medical equipment provided to long-term care residents. Your responsibilities will include handling physicians" orders for designated doctors, medical offices, and nursing homes, while focusing on building and maintaining strong relationships with physicians, nursing home staff, and Gentell field representatives. The primary focus of your role will be to track and collect Certificates of Medical Necessity (CMNs) for 80% of your time. You will be expected to develop efficiencies in departmental processes to ensure the timely return of physicians" orders, as well as handle special accounts with care. Additionally, you will be responsible for collecting signatures on physicians" orders within your assigned territory. To excel in this role, it is essential to possess excellent verbal and written communication skills, as well as strong customer service abilities. You should be persistent, results-oriented, and have a drive to succeed both independently and as a part of a team. Strong organizational skills, attention to detail, and a strong work ethic are also key qualities for this position. Furthermore, you should be able to follow through to resolve outstanding issues promptly, work with a sense of urgency, and maintain a high level of responsiveness. Confidentiality and discretion are crucial aspects of this role, and proficiency in using Microsoft Office and Adobe Acrobat is preferred. If you are looking to join a company committed to continuous improvement for both customers and employees, and if you possess the necessary skills and qualities for this role, we encourage you to apply and be a part of our dedicated team at Gentell.,