Regulatory Affairs, Team Lead

Position Summary

This is an entry-level management position that supports and leads the Product Management Regulatory Affairs team supporting the Anesthesia and Emergency Medicine(AEM) business unit. This team supports all aspects of AEM portfolio’s product lifecycle, including design, development, and global registrations. 

Principal Responsibilities

1.    Lead team of Regulatory Affairs (RA) members, utilizing strong technical regulatory skills to assist with the development of strategies for complex projects and issues.
2.    Assist in the mentoring and development of RA members, as required. Guide RA members in various aspects of design control and global regulatory submissions (including 510(k)s, EU MDD/MDR Technical Documentation, Health Canada licenses).
3.    Support RA members as necessary during meetings, negotiations, and interactions with various regulatory agencies and/or notified bodies during the development and review process to ensure successful submission (including during audits). 
4.    Support the Sr. RA Manager with regulatory tasks and initiatives, including activities related to EU MDR implementation and provide regulatory input to product lifecycle management.
5.    Proactively identify issues that may create regulatory obstacles; investigate and propose solutions to address these issues; escalate to management, if necessary.
6.    Prepare regulatory impact assessments and relay the information to wider regulatory teams and project teams, as applicable.
7.    Conduct appropriate research to develop strong regulatory strategies and positions.
8.    Review and provide feedback based on US FDA, EU MDR, Canada MDR requirements for all technical documentation, including, but not limited to, design verification & validation protocols & reports, risk management files, usability protocols & reports, manufacturing process information, biocompatibility evaluation reports, general safety and performance requirements, declaration of conformity, clinical evaluations, clinical investigations and post-market planning and reporting. 
9.    Provide regulatory input for reviews of promotional materials and product labeling as they relate to regulatory registration and commercialization of medical devices. 
10.    Assist in regulatory due diligence processes as needed.
11.    Oversee the organization and preparation of regulatory submissions and all applicable documentation. 
12.    Support CAPAs, NCs, and other quality efforts.
13.    Support implementation and modification of regulatory systems and processes in alignment with Teleflex’s regulatory initiatives.
14.    Monitor impact of evolving global regulations regarding submissions, practices, and procedures and communicate to internal stakeholders.
15.    Adhere to and ensure the compliance of Teleflex's Code of Ethics, all Company policies, rules, procedures and housekeeping standards.
 

Education / Experience Requirements

•    A bachelor's degree is required, ideally in a scientific discipline such as biology, microbiology, chemistry, engineering, medical technology, or equivalent work experience.
•    4+ years of experience working with medical devices, in a FDA (Food and Drug Administration) or ISO International Organization for Standardization) regulated environment.
•    Experienced with preparation and successful domestic and/or international submissions.
 

Specialized Skills / Other Requirements

1.    Orientation for detailed work with emphasis on accuracy and completeness.
2.    Strong leadership and interpersonal skills that include working well in a team environment and the ability to lead others.
3.    Effective written and oral communication skills; ability to succinctly and accurately communicate to various levels of management.
4.    Good organizational and planning skills; ability to handle multiple tasks and to prioritize, schedule, and delegate work to meet business needs with minimal supervision.
5.    Effective analytical/problem solving skills; ability to exercise reasonably independent judgment and discretion within a defined range of policies and practices.
6.    Working knowledge of international requirements and quality systems.
7.    Proficient in Microsoft Office – PC, Word, Excel, PowerPoint, Outlook.