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Teleflex · 2 days ago

Sr. Regulatory Affairs Associate

Wyomissing, PA

Full-time

Onsite

Mid, Senior Level

2+ years exp

Teleflex is a global provider of medical technologies dedicated to improving health and quality of life. The Sr Regulatory Affairs Associate will handle various regulatory activities to ensure compliance with submission and quality system requirements, partnering with product management to support regulatory deliverables.

CommercialHealth CareMedicalMedical Device

Hiring Manager

Debbie Riemer

Responsibilities

Support 510(k)s and associated documents, EU MDR submissions, and Health Canada license applications and amendments

Prepare electronic submission compilations for the United States (US), Canada, and EU markets

Update and maintain EU MDR technical files and documentation to ensure continued compliance

Support regulatory compliance activities, including Health Canada license renewals, Food and Drug Administration (FDA) product device listings, establishment registrations, inspections, audits, etc

Support regulatory requests for global markets

Update and maintain regulatory trackers, databases, and submission files

Apply understanding of the quality systems to job activities and projects

Update and maintain market authorization and regulatory submission/correspondence files

Support IPN and GTIN requests

Execute SAP ship control transactions to release, hold, or end product commercialization for the US and Canadian regions

Generate trending and metric reports, e.g market authorization review times, change order review times, project time tracking. Maintain submission trackers

Coordinate worldwide submission change notifications and regulatory impact assessments. Communicate the impact and support required for regulatory activities

Update applicable quality system procedures to ensure continued compliance

Qualification

Medical device regulatory experience510(k) submissionsEU MDR submissionsHealth Canada license applicationsQuality Systems knowledgeAnalytical skillsProficient with Microsoft OfficeProficient with Adobe AcrobatProficient with AgileProficient with SAPEffective communication skillsOrganizational skillsInterpersonal skills

Required

A bachelor's degree, preferably in a scientific discipline such as biology, microbiology, chemistry, engineering, or medical technology

Minimum 2 years of medical device regulatory experience or equivalent

Basic experience with preparing 510(k) submissions, EU MDR Technical Documentation Files, or Health Canada license applications

Basic experience with change control process and assessments

Basic experience working with cross-functional teams

Orientation for detailed work with emphasis on accuracy and completeness

Effective written and oral communication skills

Good organizational and planning skills; drives for results

Effective analytical/problem-solving skills

Good interpersonal skills that include working well in a team environment

Ability to exercise reasonably independent judgment and discretion within a defined range of policies and practices

Ability to work independently and effectively manage and prioritize numerous projects and responsibilities to meet business needs with routine supervision

Must be flexible, able to adapt easily, and willing to take initiative and lead regulatory projects

Proficient with Microsoft Office, Adobe Acrobat, Agile, and SAP

Preferred

Basic medical device global regulatory knowledge base (outside of the US, EU, and Canada): submissions, marketing approvals, licensing, registrations, and renewals

Knowledge and experience with design control, change assessments, labeling requirements, etc

Experience and knowledge of Quality Systems requirements and processes