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, Rüsch, 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.
Position SummaryJunior member of the complaint Intake & Reporting team, responsible for evaluating complaints to determine if they need to be reported to regulatory bodies like the FDA, prepare and submit necessary reports, and gather additional information as required during the complaint process.
This role is ideal for someone detail-oriented and passionate about regulatory processes.
Key ResponsibilitiesReceive, review and accurately document and process product complaints in line with regulatory and internal requirements.Use excellent communication skills when contacting the customer to follow up on a complaint to gather additional information regarding the complaint file.
This also includes drafting responses to customers as needed.Under limited supervision, prepare and submit regulatory reporting documentation such as MedWatch forms with FDA and Vigilance Reports with Canadian and European regulatory authorities.Support other activities in the post-market surveillance system as it develops including audits.Work to meet team KPI's Department Metrics and over QA/RA goals and objectives.Support improvement projects in the complaint intake and reporting function.Support wider QMS and risk management activity as required.Education / Experience RequirementsB.S.
Degree in Nursing, Biomedical Engineering, or related science discipline.At least 1 year experience in the medical device industry or clinical trials sector preferable.Skilled in use of Microsoft suite of applications i.e., Excel, Outlook, and Word to perform diverse clerical functions within a professional work environment.Specialized Skills / Other RequirementsSelf-driven and self-confident to prioritize tasks, with cultural awareness and sensitivity.Critical thinking and awareness to escalate to the appropriate function for appropriate action.A flexible, motivated, self-starter capable of working from their own initiative.Advanced knowledge of Word, Excel, PowerPoint, Outlook.Effective administration, organizational and prioritization skills.Strong attention to detail.The ability to work effectively to strict deadlines.Strong report writing & communication skills.The ability to interface with all levels of management in a competent manner.Note: As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities will evolve and change over time.
Teleflex is an equal opportunity employer.
Applicants will be considered without regard to age, gender, race, nationality, ethnicity, civil status, family status, sexual orientation, disability, religion and/or membership of the traveller community.
If you require accommodation and support to apply for a position, please contact us at ******.
Diversity fosters innovative thinking and entrepreneurship and that's what we are about at Teleflex.
We trust and value our people and their diversity and we make it fun to work here.
We are on a journey to ensure our workplaces mirror the patients we serve and the communities we operate in.
Our approach is simple, we embrace everyone and want them to feel they belong here.
We are building a culture where all employees can bring their best and unique selves to work.
If that appeals to you, we would love to hear from you.
Come join a company where diversity is sought out and inclusivity is how we progress.
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.
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