Regulatory Affairs Specialist

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.

Regulatory Affairs Specialist

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.