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W. L. Gore & Associates · 2 days ago

Regulatory Affairs Product Associate

United States

Full-time

Hybrid

Mid Level

3+ years exp

W. L. Gore & Associates is seeking a Regulatory Affairs Product Associate to join their Peripheral Business Group. The role involves planning and developing regulatory strategies for obtaining global marketing approvals for medical devices, as well as coordinating regulatory submissions and ensuring compliance with regulations.

Health CareManufacturingMedical Device

No H1B

Responsibilities

Work closely with technical, regulatory affairs, research associates, and product specialists to develop strategies and approaches for obtaining and maintaining regulatory approvals

Coordinate activities and timelines with applicable functional groups to complete regulatory submissions

Evaluate product labeling, product claims, advertising, specifications, and changes for regulatory compliance

Interact closely with and counsel functional groups in the business to provide regulatory guidance and review of their activities

Integrate into the Regulatory Affairs team to facilitate collaborative and consistent regulatory counsel to product functional groups

Represent Regulatory Affairs in quality system audits by external agencies

Assist with post-market compliance requirements

Collaborate with and counsel the clinical team to ensure notifications and other reports are submitted as required during the course of clinical trials

Maintain compliance with training expectations as required for this position

Additional responsibilities as required within the scope of position

Qualification

Regulatory Affairs experienceRegulatory strategies formulationFDA regulations knowledgePMA submissions experienceClass III device dossiersCommunication skillsAttention to detailOrganizational skillsInterpersonal skills

Required

Bachelor's degree

Minimum 3 years of Regulatory Affairs experience in the medical device industry

Experience formulating and implementing regulatory strategies and writing comprehensive regulatory documents

Demonstrated success regarding the assessment of proposed changes to medical device design, specifications, materials, manufacturing methods or equipment, supplied components, packaging, or sterilization

Experience proactively identifying necessary submission content and assessing the project documentation, including compliance with international standards

Knowledge of FDA and international regulations related to Class II and Class III implantable medical devices

Good communication (oral, written, and interpersonal skills)

Attention to detail and good organizational skills; ability to prioritize work and adapt to shifting priorities

Ability to interact effectively with many diverse functional groups

Ability to travel up to 15%