associate director of regulatory operations - labeling.

• fort worth , texas

• posted july 12, 2024

job details

summary

• $60 - $71.43 per hour

• contract

• bachelor degree

• category life, physical, and social science occupations

• reference48467

job details

job summary:

As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!

Position Overview: 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.

location: Fort Worth, Texas

job type: Contract

salary: $60.00 - 71.43 per hour

work hours: 9 to 5

education: Bachelors

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 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.

skills: GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory Affairs Strategy, Regulatory Briefing Documents, Medical Device Product Development

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.