Senior Regulatory Affairs Manager

Description

Site Overview:

Since 1900, Young Dental’s philosophy has been to create, innovate, and support the dental industry with exceptional products. Today, we are proud to be one of the world’s largest manufacturers of disposable prophy angles and preventive dental products.

Role Overview:

Reporting to the VP, QARA, the Sr. Regulatory Affairs Manager will be responsible for managing regulatory affairs for medical devices, drugs, tissue, and other products in Young Innovations (YIs) portfolio. The incumbent will be responsible for assuring compliance with domestic and international regulations. The individual will develop the regulatory strategy for products and processes by interfacing with regulatory bodies, consultants, and internal team members.

Qualifications

Responsibilities:

• Establish regulatory strategies to ensure the compliance of products and processes that are part of YIs commercial activities. Provide input for regulatory requirements and regulatory strategies on product development to ensure timely submission and approval
• Responsible for performing all duties in compliance with ISO13485, Medical Device Regulation EU 2017/745, Medical Device Directive 93/42/EEC (and all applicable amendments), FDA's Quality Systems Regulations, GMP's, Canadian Medical Device Regulations; and other international regulatory requirements.

• Manage the Regulatory Affairs department, ensure the effectiveness, development, and empowerment of employees. Manage the Artwork Development department to ensure that labeling of all products meets regulations of the country of distribution. Ensure an effective administration of resources and support of projects.
• Prepare and submit International regulatory applications and filings including US FDA 510(k) submissions, Technical Files, and Design Dossier submissions, as well as prepare internal regulatory file documentation.

• Participate in medical device product development teams and develop overall regulatory strategy that delivers on project costs, timeline and FDA approval. Ensure that project work proceeds according to agreed deadlines and maintain status records. Provide input on and review of protocols and reports for design verification and validation for material, process and facilities changes, assay/method validation, shelf life, clinical and non-clinical studies, material qualification and safety testing in support of product submissions and marketing collateral
• Participate in root cause analysis, corrective and preventive actions for product and process issues, including internal and external audits, as necessary.
• Maintain regulatory affairs documents and systems including the Regulatory Product Submissions and Regulatory Tracking database.
• Evaluate changes to controlled documents for impact on submissions and filing requirements, including providing a technical review of and approval for proposed changes and supporting documentation
• Determine governmental regulations affecting Company processes and assure the processes are complete and accurate to ensure company compliance. Formulate and implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
• Support external audits and government inspections.
• Conduct regulatory assessments, remediation, and integration activities in support of company acquisitions.

Related Duties:

• Honest, flexible, dependable, self-motivated team player with the ability to work autonomously.
• Strong interpersonal skills, effective written and verbal communication, problem solving and decision making skills and ability to interact with all levels of management.
• Ability to collaborate and lead in a cross-functional team environment and a flexible team-oriented perspective.
• Expertise in technical and operational aspects of regulatory affairs, combined with scientific understanding and strong project management.
• Must be process-oriented and have the ability to analyze, deconstruct, develop, and institute processes to support the business.
• Effectively prioritizes workload and manages time to complete multiple projects within established timelines and goals with minimal supervision in a fast-paced, interrupt-driven environment.
• Expertise in Microsoft Office applications is required, specifically Microsoft Word, Excel, Outlook, Project, PowerPoint, and SharePoint.

Qualifications:

• Bachelor’s degree in engineering, science or a related technical field, required.
• 5 years of experience in Regulatory Affairs.
• Working knowledge of regulatory approval for medical device submissions (510K, Design Dossier, etc.), required.
• Working experience of Unique Device Identifier (UDI) regulations.
• Working knowledge of FDA Quality Systems Regulations, GMP's, ISO 13485, Medical Device Regulation EU 2017/745, Medical Device Directive 93/42/EEC, ISO regulations/standards, including ISO 13485, 10993, 14971, strongly preferred.
• Experience in analyzing and developing strategies for regulatory submissions and compliance issues including, but not limited to successful development and implementation of regulatory strategy for Class II or Class III medical devices resulting in global regulatory product approvals, strongly preferred.
• Experience with medical device product development; regulatory manufacturing device registrations, quality system , new product development, design controls.
• Working knowledge of International regulations with specific experience with Medical Devices.
• Experience managing, developing, organizing, and maintaining regulatory files.
• Demonstrated track record of successful regulatory submissions.

Working Conditions:

• Office environment and occasional exposure to manufacturing plant environment, with some abnormal variations in temperature, unavoidable fumes, noise, dust and atmospheric conditions.
• Travel Required: Up to 20%

Young Innovations, Inc. is an Equal Opportunity Employer and E-Verify participating employer.