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GRAO Labeling Associate Director

Edgecliff Vlg, TX 76134

Posted: 08/21/2024 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 612977 Is job remote?: No Country: United States

Job Description


Target Pay Rate: 60-71.42/hr **salary will be commensurate with experience 

Position Purpose:

The Associate Director of Regulatory Operations - Labeling will lead and oversee the strategic and operational aspects of regulatory labeling for medical devices. This role is essential in ensuring that all labeling activities comply with international regulations and standards, while effectively managing labeling content and artwork approvals. The position is responsible for advancing regulatory labeling practices, enhancing labeling processes, and integrating technology to streamline future operations.

Functional/technical know-how:

Individual must have a deep understanding of global medical device regulations, including FDA 21 CFR Part 801, European MDR/IVDR, and other relevant standards. Familiarity with ISO standards related to labeling, such as ISO 15223-1 and ISO 13485, and knowledge of labeling requirements across major markets, including the US, EU, and Canada - additional regions a plus. Ability to think strategically, navigate ambiguity and make decisions.

Major Accountabilities:
  • Regulatory Labeling Compliance:
  • Develop and implement labeling strategies to ensure compliance with global medical device regulations and standards, including FDA, CE Marking, and ISO.
  • Content and Artwork Management:
  • Oversee the management, review, and approval of Medical Device Master Labeling Content and artwork for various products, ensuring regulatory and internal compliance.
  • Regulatory Objectives Support:
  • Support regulatory objectives such as Post Production Risk Reviews (PPRR), Clinical Evaluation Report (CER), labeling gap assessments, and labeling technical documentation.
  • Regulatory Harmonization:
  • Manage and implement harmonization activities to ensure consistent labeling across different markets and handle variations in response to regulatory changes.
  • Technology Integration:
  • Lead efforts to integrate advanced technologies and automation solutions to enhance labeling processes and operational efficiency.
  • Continuous Improvement:
  • Drive continuous improvement initiatives to optimize labeling processes, increase efficiency, and ensure regulatory compliance.
  • Expertise and Training:
  • Provide expertise in regulatory standards, mentor team members, and stay current with industry trends and regulatory changes.

Education: Bachelors degree in Life Sciences, Regulatory Affairs, or a related field. Advanced degree (Masters or Ph.D.) is preferred.

Languages: Fluency in English essential

Experience/Professional Requirement: Minimum of 7-10 years of experience in regulatory affairs or labeling for medical devices, with significant experience in managing labeling content and artwork approvals.

Competencies: Manages Complexity Action Oriented Drives Results Communicates Effectively Manages Ambiguity

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Edgecliff Vlg, TX

Ready to take the next step in your career? Explore exciting job opportunities in the vibrant area around Edgecliff Village, Texas! Nestled in the heart of Tarrant County, this charming community offers a unique blend of urban amenities and small-town charm, making it a perfect place to grow both personally and professionally. From the stunning views at Eagle Mountain Lake to the lively arts scene at the Amon Carter Museum of American Art, there is something for everyone here. Indulge in mouthwatering Tex-Mex cuisine, catch a performance at the Bass Performance Hall, or cheer on the Dallas Cowboys at AT&T Stadium. Don't miss out on the endless opportunities for career advancement and a fulfilling lifestyle that Edgecliff Village has to offer!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.