Sr Regulatory Affairs Specialist

Position Summary

Teleflex is investing in our capability to drive material cost improvement opportunities as part of a strategic corporate approach to reversing recent trends in cost escalation and generating significant stakeholder value. Recent challenges in the market for materials used in the medical device industry, coupled with commercial and post-COVID environmental challenges, have placed significant pressure on the total cost of goods sold. The role of the Senior Regulatory Affairs Specialist is focused on supporting material cost improvement projects that will shift this dynamic, reduce costs, and enhance product margins.

Under Strategic Regulatory Affairs Team Management, the Senior Regulatory Affairs Specialist will develop strategies and regulatory submissions for Material Cost Improvement Projects (CIP) and address issues related to regulatory documents, investigations, product development planning, and regulatory agency interactions. This position will collaborate with Quality Assurance, Supply Chain, Commercial and with other Regulatory functions to ensure projects align with the commercial objectives of the business.

INDIVIDUAL CONTRIBUTORS:

•    Commitment to Goals –A strong commitment to achieving goals is essential for personal and team success. It requires taking ownership of tasks, staying focused on priorities, and consistently delivering high-quality work. Being proactive, managing time effectively, and seeking support when needed are critical to meeting deadlines and overcoming challenges. By aligning personal efforts with team and organizational objectives, individual contributors play a vital role in driving results and advancing shared goals.

•    Continuous Improvement - Continuous improvement means actively seeking ways to enhance your work, skills, and contributions. It's critical to stay curious, embrace feedback, and look for opportunities to streamline processes or solve problems more effectively. Individual contributors should take initiative to learn from experiences, adapt to change, and apply new knowledge to drive better outcomes. By consistently striving to improve, they add value to their team and support the organization’s growth and success.

•    Culture and Values – Living our culture and values is essential to fostering a positive, collaborative work environment. Individual contributors demonstrate this by treating others with respect, acting with integrity, and contributing to an inclusive and supportive team culture. It's critical to hold oneself accountable, align actions with shared values, and support the broader mission of the organization. By consistently modeling these behaviors, individual contributors help strengthen the workplace culture and positively influence those around them.

Principal Responsibilities

•    Provide Regulatory support and serve as the RA Lead in the team driving Material CIP program. 
•    Support new supplier/vendor changes. 
•    Identify key risks on Material CIP Program and communicate appropriately into the Project Lead to ensure all regulatory impacts are captured for each project.
•    Support the Program Lead in developing RA timelines in line with project charters and implementation plans

•    Collaborate with the appropriate RA functional peers to establish key risks and develop program implementation plans. 
•    Manage Technical Documentation. 
•    Manage Global regulatory impact assessments. 
•    Review and assess change control activities for potential impact on current regulatory filings
•    Work with Program lead to estimate the resources and participants needed to achieve project goals
•    Proactively manage changes in project scope, identify potential risks, and devise contingency plans
•    Manage stakeholder communication to ensure project status and/or related issues are effectively communicated.
•    Work with Quality, Operations, Engineering and other internal groups to investigate and recommend solutions to address potential regulatory issues. 
•    Ensure all operations are fully compliant with license details and updated in accordance with relevant guidelines and directives.
•    Interact and negotiate with regulatory authorities during the development and review process to ensure submission approval as well as during audits to mitigate any potential risks.

Education / Experience Requirements

•    Bachelor Degree in Science or Engineering disciplines. 
•    Minimum 5+ years of experience working within medical device industry; 3+ years with Class II or higher registrations. 
•    Knowledge and understanding of US, EU and Canada medical device regulations, standards, and guidance documents.
•    Quality Assurance (21 CFR 820, ISO 13485) and Risk Management (ISO 14971) experience required
•    Excellent technical writing experience within a medical device environment – essential
•    Attention to detail and accuracy – essential
•    Fluent in English, both written and oral – essential
•    Ability to work well under deadlines and pressure
•    Problem solving skills for developing creative solutions and meeting objectives are required.
•    Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel)
•    Ability to prioritize tasks and manage several projects and tasks simultaneously; and to interface with all levels of management

Specialized Skills / Other Requirements

•    Experience with Corrective Action, Manufacturing and Design Control concepts desired
•    Computer literate (i.e., statistical software and analysis, excel, word processing for report generation, PowerPoint presentations, etc.)
•    Positive attitude and ability to operate and communicate effectively with multiple teams & leadership
•    Ability to reason, support and prioritize projects, adapt to shifting priorities, effectively solve problems / conflicts, and proactively effect change

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