Medical Device Labeling Specialist

Medical Device Labeling Specialist

Compliance

Marlboro, MA

Healthcare

JO-1905-1228

Job Description

We are looking for an experienced Medical Device Labeling Specialist to develop corporate procedures for labeling, UDI and EUDAMED in compliance with all key internal and external global regulatory requirements including EU Medical Device Regulation (MDR). The role will work collaboratively with the divisional representatives to gather feedback on new processes to ensure alignment and to better support their business. Works with the Information Services (IS) team to identify changes needed into the systems to support new requirements.

Responsibilities

Responsible for the development of corporate SOPs (Standard Operating Procedures) for Labeling, UDI and EUDAMED in compliance with the internal and key external global regulatory requirements including EU MDR.

Ensures all corporate procedures impacted by the new procedures are identified, assessed for updates, changes needed and that these changes are completed as appropriate.

Develops and maintain a quality plan to define all key milestones needed to develop the procedures, system changes, validation etc. to maintain the integrity of the Corporate Quality Systems during the implementation of these new processes.

Develops and maintains a detailed project plan if needed to support these activities.

Serves as labeling process owner from an RA perspective.

Plans, tracks and executes on medical device labeling deliverables for new and sustaining product lines.

Requires mastery of medical device labeling symbols, UDI, and EU MDR labeling requirements.

Liaise with Regulatory Affairs members and other cross-functional teams (e.g., supply chain, legal, clinical, R&D, Tech Comm, QA, etc.) to ensure the accuracy of all information included on the label or in the labeling.

Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives.

Develops and revises QMS procedures and work instructions for medical device labeling.

Has regulatory experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways.

Demonstrated ability to proactively manage product labeling needs for new product development and sustaining products.

Strong emphasis on exceeding customer expectations and maintaining FDA/ISO and other regulatory compliance.

Thorough understanding of US, EU, and ROW labeling regulations.

Participate in project management meetings as the Regulatory representative.

Review and approve Change Orders for Regulatory compliance, including drawings and labeling changes.

Support preparation (markup/annotate and clean) packaging and labeling components.

Works with vendors/contractors to ensure adequate and timely support of project, compliance and proofreading activities.

Skills

Current knowledge of relevant US and International Regulations (including but not limited to); FDA QSR (21CFR 820,), ISO Requirements, GMP, MDD (Directive 93/42/EEC) MDR (Regulation (EU) 2017/745), and ability stay abreast of regulations pertinent to medical devices, and combination products.

Practical knowledge of Project Management including experience managing complex projects with cross-functional teams.

Knowledge of labeling workflow from creation to obsolescence; Prior experience in team management in a matrix organization.

Experience with equipment like LVS for label verification to standard.

Ability to work independently and autonomously.

Working knowledge of appropriate global medical device regulations, requirements, and standards.

Strong knowledge of AI's/Application Identifiers.

Experience

Bachelor's degree (BA) Scientific, Regulatory or Graphics Design - Required U.S. Bachelor's Degree (4-year university degree) or ex-U.S. equivalent. Degree or background in life sciences, technical (engineering) or related field.

Have 8+ years prior RA experience - Minimum five years direct experience in an FDA or EU Regulated environment a must, preferably with respect to the release of labeling and UDI.

Experience with translation activities desirable; Experience with EU MDR

Regulatory background should include the medical device.