Principal Regulatory Affairs Specialist

Position Summary

The Principal Regulatory Affairs – Strategic Operations position will focus on the regulatory activities and deliverables to strategically assess and support related regulatory tasks including simple to complex submission writing. This role will be responsible for strategy and facilitating compliant, streamlined execution of regulatory affairs activities related to the implementation of multi-business unit operations initiatives. This role is responsible for effectively partnering with PM RA, Regional RA, Reg OPs and cross-functional teams and a varied group of stakeholders to aide in regulatory strategy and execution for operations programs.

Principal Responsibilities

•    Conduct appropriate research using standards, guidance documents, previous assessments and other resources to develop strong regulatory assessments and strategies for the US, EU and Canada for new and modified products.
•    Independently develop comprehensive regulatory strategies relating to PMA, IDE, ‘’510(k) premarket notifications, EU MDD Technical File/MDR Technical Documentation, and Canadian license submission / amendments to support multi-business unit operations programs.
•    Partner with Regional RA to develop global registration strategies of product in foreign markets and communicating needs to product cross-functional teams.
•    Interact and negotiate with regulatory agencies / Notified Bodies to support product life cycle management, including FDA for Class II and III Pre-Submission Meetings and PMA submissions, Health Canada for Class III/IV submissions, and EU MDR Class I – IV submissions and change notifications. 
•    Work with Quality, Operations, Engineering, and other internal groups to investigate and recommend solutions to address potential regulatory issues and impacts.
•    Support regulatory agency and/or notified body audits by as needed.
•    Participate in and ensure compliance with design controls and review design documentation to confirm regulatory requirements are met.
•    Participate in development and approval of risk activities as well as other deliverables as related to projects.
•    Provide regulatory review for reporting activities required by EU MDR (i.e. post-market surveillance, reporting, etc.).
•    Review and approve all labeling (product, advertising and promotional) and ensure claims are substantiated for all classes of classes.
•    Assist in regulatory due diligence process as needed.
•    Proactively drive RA project deliverables by collaborating cross-functionally and engaging with cross-business unit team members as needed.
•    Monitor impact of changing evolving global regulations on submissions, practices and procedures and communicate to internal stakeholders and leaders.
•    Propose solutions for Regulatory Affairs questions/issues to RA management.
•    Review and propose updates to department procedures for process improvement and ongoing updates related to regulatory compliance. 
 

Education / Experience Requirements

•    Bachelor’s degree in a science or engineering field, or equivalent work or educational experience. 
•    7+ years of Medical Device Regulatory Affairs experience, domestic and international or equivalent experience. 4 years of experience with Class I, II and III medical devices.  
•    Experience with facilitating both internal and external audits, i.e. BSI, FDA. 
•    Proven history of successful domestic and international submissions
 

Specialized Skills / Other Requirements

•    Knowledge in multiple therapy and sterilization types
•    Proven expertise in global aspects of regulatory, including compliance, design control, and risk management activities.
•    Strong regulatory affairs experience, including excellent understanding of regulatory processes for registrations and modifications in a Global environment.
•    Strong understanding of interrelationships across various functions and their impact on the business and strategic planning.
•    Experienced in leading agency interactions and soliciting formal and informal regulatory body feedback on strategies and scenarios.
•    Demonstrated ability to work cooperatively at all levels in a matrix organization to build and maintain the positive relationships required to accomplish project goals
•    Customer service / issue resolution and proactive problem-solving skills
•    Computer literate (word processing, spreadsheets, databases)
•    Strong negotiation skills and the ability to communicate effectively
•    Strong analytical and critical thinking skills.
•    Strong interpersonal, analytical, writing, and organizational skills, including the ability to “navigate the grey”
•    Ability to work independently or collaboratively to determine and develop solutions
•    Strong verbal/ written communication and presentation skills. Demonstrated ability to succinctly and accurately communicate to various levels of management and across the organization
•    Excellent decision-making skills. Ability to negotiate and balance decisions and manage competing priorities across multiple functional areas
•    Ability to manage and prioritize multiple projects to meet deadlines that align with the Business Unit’s objectives with minimal oversight. 
•    Ability to analyze and resolve non-routine regulatory issues using independent judgment. 
•    Proven track record of working as a team player to overcome obstacles and complete tasks through collaboration. 
•    Ability to operate in multiple Quality Systems. 
•    Proficiency in MS Office software programs. 
•    RAC certification is a plus. 
 

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