Teleflex
Sr. Regulatory Affairs Specialist
Teleflex, Osseo, Minnesota, United States, 55311
Expected Travel : Up to 10%
Requisition ID : 11063
About Teleflex Incorporated
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.
Teleflex is the home of Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rsch™, UroLift™ and Weck™ - trusted brands united by a common sense of purpose.
At Teleflex, we are empowering the future of healthcare. For more information, please visit
teleflex.com .
Global Operations -
Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.
Position Summary
Support the Strategic Manufacturing group to coordinate completion of global submissions and registration documents in support of manufacturing transfer projects and track their progress against planned timelines. Submissions will be at moderate to complex level, and relate to regulatory documents, submissions, investigations, product development planning and regulatory agency interaction. The candidate is required to work effectively with cross-functional virtual groups and global regulatory affairs contacts to maintain worldwide Regulatory clearances/approvals. The candidate is also responsible for staying abreast of evolving global regulatory requirements.
Principal Responsibilities•Develop and complete regulatory planning activities for the applicable strategic manufacturing projects.•Experience with medical device manufacturing facility transfers and legal manufacturer change.•Review and assess strategic manufacturing activities for potential impact on worldwide regulatory findings.•Clearly communicate regulatory requirements for the strategic manufacturing projects to project and program manager.•Ensure compliance with design controls and good manufacturing practices.•Apply understanding of the quality systems to job activities and projects.•Participate in project meetings to ensure that the teams remain compliant with regulatory requirements during the planning, execution, and closure of the projects.•Assist in producing new or revised global medical device submissions in the format consistent with the governing SOP's.•Develop timelines, coordinate receipt of technical information from appropriate sources and manage the preparation of responses to regulatory agency questions and/or requests for information.•Liaise with Business Unit Regulatory Affairs functions to track and monitor regulatory submission timelines, facilitate recurring meetings, and provide meeting minutes.•Manage regulatory specific project deliverables and interdependencies; communicate risks or delays in a timely manner.•Identify risk factors and contingency planning for assigned projects.•Bring Regulatory Affairs questions/issues to the attention of RA management.•Interface with various departments to collect and organize required documentation materials.•Keep abreast of relevant domestic, European, and other international regulatory requirements for medical devices.•Mentor junior staff in the application and execution of regulatory activities and business processes.•Adhere to and ensure the compliance of Teleflex's Code of Ethics, all company policies, rules, procedures, and housekeeping standards.
Education / Experience Requirements•Degree; desired four-year college degree in Science or Engineering disciplines.•Minimum 6 years' experience working within medical device industries; 3+ years with Class II or higher registrations.•Knowledge and understanding of US and international medical device regulations, standards, and guidance documents.
Specialized Skills / Other Requirements•Excellent verbal and written communication skills - essential•Attention to detail and accuracy - essential•Complex problem-solving skills for developing creative solutions and meeting objectives independently and as part of a team - essential•Experience participating in several projects concurrently•Self-driven and ability to work independently and/or as a team player•Strong analytical and critical thinking skills; capable of understanding the impact of decision making on both Teleflex Medical and its customers•Effective communicator of issues and able to propose ideas or solutions to senior members of the organization•Approachable and enthusiastic•Flexible and adaptable to dynamic project timelines•Good organizational skills with cultural awareness and sensitivity•Goal oriented; displays ownership of results and a drive to achieve•Experience working with remote teams•Knowledge of electronic document management systems•Ability to apply Business and Regulatory Affairs ethical standards•Proficiency in MS Word, Excel, Power Point, and Outlook
#LI-EB1
Working Conditions / Physical Demands
TRAVEL REQUIRED: Up to 10%
WORKING ENVIRONMENT:Office/ProfessionalPlant/ManufacturingRemote/FieldLaboratory
At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.
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: 877-880-8588 or Talent@Teleflex.com.
Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.© 2024 Teleflex Incorporated. All rights reserved.
Requisition ID : 11063
About Teleflex Incorporated
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.
Teleflex is the home of Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rsch™, UroLift™ and Weck™ - trusted brands united by a common sense of purpose.
At Teleflex, we are empowering the future of healthcare. For more information, please visit
teleflex.com .
Global Operations -
Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.
Position Summary
Support the Strategic Manufacturing group to coordinate completion of global submissions and registration documents in support of manufacturing transfer projects and track their progress against planned timelines. Submissions will be at moderate to complex level, and relate to regulatory documents, submissions, investigations, product development planning and regulatory agency interaction. The candidate is required to work effectively with cross-functional virtual groups and global regulatory affairs contacts to maintain worldwide Regulatory clearances/approvals. The candidate is also responsible for staying abreast of evolving global regulatory requirements.
Principal Responsibilities•Develop and complete regulatory planning activities for the applicable strategic manufacturing projects.•Experience with medical device manufacturing facility transfers and legal manufacturer change.•Review and assess strategic manufacturing activities for potential impact on worldwide regulatory findings.•Clearly communicate regulatory requirements for the strategic manufacturing projects to project and program manager.•Ensure compliance with design controls and good manufacturing practices.•Apply understanding of the quality systems to job activities and projects.•Participate in project meetings to ensure that the teams remain compliant with regulatory requirements during the planning, execution, and closure of the projects.•Assist in producing new or revised global medical device submissions in the format consistent with the governing SOP's.•Develop timelines, coordinate receipt of technical information from appropriate sources and manage the preparation of responses to regulatory agency questions and/or requests for information.•Liaise with Business Unit Regulatory Affairs functions to track and monitor regulatory submission timelines, facilitate recurring meetings, and provide meeting minutes.•Manage regulatory specific project deliverables and interdependencies; communicate risks or delays in a timely manner.•Identify risk factors and contingency planning for assigned projects.•Bring Regulatory Affairs questions/issues to the attention of RA management.•Interface with various departments to collect and organize required documentation materials.•Keep abreast of relevant domestic, European, and other international regulatory requirements for medical devices.•Mentor junior staff in the application and execution of regulatory activities and business processes.•Adhere to and ensure the compliance of Teleflex's Code of Ethics, all company policies, rules, procedures, and housekeeping standards.
Education / Experience Requirements•Degree; desired four-year college degree in Science or Engineering disciplines.•Minimum 6 years' experience working within medical device industries; 3+ years with Class II or higher registrations.•Knowledge and understanding of US and international medical device regulations, standards, and guidance documents.
Specialized Skills / Other Requirements•Excellent verbal and written communication skills - essential•Attention to detail and accuracy - essential•Complex problem-solving skills for developing creative solutions and meeting objectives independently and as part of a team - essential•Experience participating in several projects concurrently•Self-driven and ability to work independently and/or as a team player•Strong analytical and critical thinking skills; capable of understanding the impact of decision making on both Teleflex Medical and its customers•Effective communicator of issues and able to propose ideas or solutions to senior members of the organization•Approachable and enthusiastic•Flexible and adaptable to dynamic project timelines•Good organizational skills with cultural awareness and sensitivity•Goal oriented; displays ownership of results and a drive to achieve•Experience working with remote teams•Knowledge of electronic document management systems•Ability to apply Business and Regulatory Affairs ethical standards•Proficiency in MS Word, Excel, Power Point, and Outlook
#LI-EB1
Working Conditions / Physical Demands
TRAVEL REQUIRED: Up to 10%
WORKING ENVIRONMENT:Office/ProfessionalPlant/ManufacturingRemote/FieldLaboratory
At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.
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: 877-880-8588 or Talent@Teleflex.com.
Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.© 2024 Teleflex Incorporated. All rights reserved.