Associate Director of Regulatory Operations

3 weeks ago


Duluth, United States Randstad Life Sciences US Full time

Immediate opportunity for an Associate Director of Regulatory Operations - Labeling, with the largest eye care device company in the world.

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.


Position Type: Contract role for 6 mos. (through Jan 2025); extention possible

Location: Johns Creek, GA OR Fort Worth, TX

Pay Range: $60/hr-$71.43/hr. UPDATED


Essential Duties and Responsibilities:

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.


Qualifications:

  • Bachelor’s degree (BS) in Life Sciences, Regulatory Affairs, or a related field. Advanced degree, Master's (MS) or Ph.D. is preferred.
  • 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.
  • 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.


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