Senior Manager, Regulatory Affairs
Teleflex

Job Info

Expected Travel: Up to 50%

Requisition ID:3625

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 teleflex.com.

OEM - Teleflex Medical OEM is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.

Position Summary

Manage all aspects of regulatory affairs associated with the OEM business unit; including writing and reviewing technical files/Design Dossiers, labeling review, design control review, and others. In addition, this position will be responsible for regulatory strategies, including US, Canadian, and EU MDR submissions, providing advice to the QARA Director and also managing interactions with the US FDA, Health Canada, Notified Bodies (ISO), and other global regulatory authorities. Will also interact with OEM customers, to support global submissions and resolve issues. Must stay current on evolving global regulatory requirements.

Principal Responsibilities

• Implementation of requirements of EU MDR, as needed, across the OEM BU.
• Identify EU MDR compliance requirements for materials used in component level products.
• Strategy for supporting needs of all of OEM, contract manufacturing, components, private label.
• Primary accountability for all US, Canadian, and EU MDR submissions for OEM.
• Responsible for determining the impact of scientific and technical information on submissions.
• Ensure compliance with product development and design control procedures during development activities.
• Responsible for review of marketing materials and determining level of control needed for marketing materials/systems.
• Work directly with Regulatory Authorities to promote agreement on filing strategies or resolve problems and provide regulatory guidance and recommendations during these processes as necessary.
• Interact with customers' Regulatory Affairs representatives to determine strategies, support product registrations and/or resolve issues.
• Interact with others to develop and ensure implementation of OEM regulatory strategies.
• Ensure compliance to these policies relative to advertising and promotional labeling review and approval.
• Ensure compliance to corporate compliance systems.
• Assist with analysis of regulatory requirements for new or significantly changed products.
• Provide guidance on Quality and Regulatory Agreements with OEM customers.
• Provide oversight and guidance of OEM regulatory affairs group for maintenance of the OEM regulatory databases.
• Support, train, and guide direct reports to meet set objectives
• Adhere to and ensure the compliance of Teleflex Code of Ethics, all company policies, rules, procedures and housekeeping standards.
• Represent OEM BU for and participate in corporate level RA projects.

Education / Experience Requirements

• Minimum of Bachelor of Science degree in a technical discipline
• Broad regulatory and Quality System knowledge base required, including global requirements for: complaint handling, adverse event reports, marketing approvals, change assessment, recalls, labeling, and quality systems.
• 6 -10 years progressive experience in medical device regulatory affairs with the following skills: technical writing, detail-oriented, good organizational skills, good computer skills, management skills, and good communication skills.
• Previous experience working in OEM or contract manufacturing. (preferred)
• Previous experience working with Regulatory Authorities relative to premarket and compliance activities.
• Experience with medical device submissions.
• Previous experience directing, managing and mentoring employees. Experience with remote staff preferred.

Specialized Skills / Other Requirements

• Strong regulatory and quality systems knowledge
• Strong communications skills, both written and verbal
• Demonstrated management skills
• Strong problem and conflict resolution skills
• Proficient with Microsoft Office Products: Word, Excel, Access, Outlook, Teams
• Excellent documentation and negotiation skills
• Strong research, logic, reasoning ability
• Strong presentation, technical writing, and training skills
• Ability to support and prioritize projects
• Strong attention to detail and the ability to adapt to shifting priorities
• Work with minimal supervision

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.

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