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Associate Director Regulatory Affairs
2 months ago
Position: Associate Director of Regulatory Operations – Labeling // Regulatory Specialist III, Req#: 3048-1
Locations: (100% Onsite)
- Fort Worth, TX
- Johns Creek, GA
Duration: 6+ Months Contract
Job Description:
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:
Individuals 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.
Must Haves:
- Bachelor’s degree in Life Sciences, Regulatory Affairs, or a related field. An advanced degree (Master’s or Ph.D.) is preferred.
- Languages: Fluency in English essential
- 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
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 Postproduction Risk Reviews (PPRR), Clinical Evaluation Reports (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.
