Director, Regulatory Affairs - Biologics

Date: Sep 19, 2023

Location: Maple Grove, MN, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 8864


About Teleflex Incorporated

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit


Anesthesia and Emergency Medicine - At Teleflex, we promote the use of advanced anesthesia and emergency medicine techniques to help improve outcomes and reduce healthcare costs. We equip clinicians with some of the most advanced medical devices on the market today, from our world-class brands including: 

  • LMA® and Rüsch® airway management devices designed to help reduce the risk of airway-related complications. 
  • Arrow pain management products designed to improve patients' post-operative pain experience. 
  • The Arrow® EZ-IO® System that helps address the time-critical challenge of emergency vascular access, and 
  • QuikClot® and QuickClot Control+® hemostatic devices, used by hospitals, EMS, and the military for hemorrhage control in a broad range of bleeding situations. 

Join a dynamic, growing team that offers healthcare providers advanced medical technology solutions that make a difference in patients' lives. 

Position Summary

The Director, Regulatory Affairs will oversee and direct all global (including U.S.) regulatory support and submissions for early to late-stage development (and commercial) biologics products. Responsible for developing and implementing innovative biologics regulatory strategies and the preparation and submission of high-quality Biologics INDs, BLAs and other device related submissions. Subsequent supplements and variations will be developed in close collaboration with in-house Clinical Operations, Manufacturing and Supply Chain and Quality teams, contract manufacturing organizations, external experts, collaborators, and strategic partners.  Liaise with regulatory authorities via written/verbal communication and lead meetings. Maintain a high-level understanding of global regulatory requirements and anticipate the impact of the changing regulatory environment on development and registration strategy.

Principal Responsibilities

•    Actively retain and drive talent development through coaching, mentoring, development assignments and other formal / informal actions and systems.
•    Develop a vision and strategy which inspires the team and drives towards the business needs.
•    Lead product focused team of Regulatory professionals, utilizing strong technical regulatory skills in developing strategies for complex projects and issues.
•    Constantly delivers improved value for all stake holders by driving and developing a culture of excellence through continuous improvement.
•    Develop, implement, and support a comprehensive regulatory compliance strategy to meet global market requirements for product(s) and ensure alignment with our overall business strategy. 
•    Management and oversight of creation, of eCTDs for biologic product submission to US and outside-US Health Authorities.
•    Manage communication with regulatory agencies, such as managing on site/remote meetings, participating in regulatory inspections, and representing the company as required.
•    Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.
•    Proactively support multidisciplinary product development teams and communicate regulatory requirements effectively.
•    Provide regulatory input to product lifecycle planning.
•    Develop strong regulatory strategies in alignment with commercial and clinical needs.
•    Determine issues which may create regulatory obstacles and investigate solutions to address these issues.  
•    Support clinical evidence and claims development.
•    Evaluate regulatory impact and support design transfer(s) and manufacturing changes.
•    Support review and approval of Labeling (product, advertising and promotional).
•    Maintain regulatory files as required by procedure.
•    Monitor impact of changing evolving global regulations on submissions, practices and procedures and communicate to internal stakeholders.
•    Adhere to and ensure the compliance of Teleflex’s Code of Conduct, all Company policies, rules, procedures, and housekeeping standards.

Education / Experience Requirements

•    Bachelor’s Degree in engineering, medical, science or related field required.  Master’s degree preferred.  
•    7 to 10 years of overall Medical Device Regulatory Affairs experience with demonstrated leadership skills. 
•    Hands-on experience in the pharmaceutical (drug and/or biologic) industry required, including but not limited to management and authorship of eCTD filings for INDs, BLAs and NDAs; regulatory strategy development, risk management, and change control participation.
•    In-depth working knowledge of FDA sections of 21 CFR parts 3.2(e), 4, 210, 211, 600, 606, 610, 640, 820.20, 820.30, 820.50 and 820.100 and precedents relevant to Teleflex products. 
•    Documented direct interface with Health Authorities via multiple modes (face-to-face, T-con, and emails).
•    Experience in working with government contracts and requirements is an advantage in this role.
•    RAC certification, preferred. 

Specialized Skills / Other Requirements

•    Ability to apply business and Regulatory Affairs ethical standards. 
•    Excellent analytical and critical thinking skills.
•    Able to travel domestically and internationally.
•    Diplomacy and negotiation skills, as well as the confidence to take unpopular decisions.
•    Demonstrated skills in leadership and development of people and teams. 
•    Capability to build and maintain effective working relationships across functions and organizations and levels.  
•    Demonstrated effectiveness with interpersonal skills and the ability to interface with cross functional teams and leadership.  
•    Demonstrated expertise in planning, budgeting, personnel development, and project management directed toward achievement of annual, long term and strategic business plans and goals.  

Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® – trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.