Job Title: Regulatory Affairs Specialist (Medical Device Industry)
Duration: 12+ Months (W2)

Job Description:
We are seeking an experienced Regulatory Affairs Specialist to support regulatory compliance and submissions for medical devices. This role is essential for ensuring compliance with FDA, ISO, and other global regulatory requirements throughout the product lifecycle, including product development, manufacturing, and post-market activities.

Key Responsibilities:
Regulatory Submissions: Prepare, review, and submit regulatory documentation, including 510(k) submissions, EU Technical Files, and Design Dossiers, to gain approval for new and modified medical devices.
Regulatory Strategy: Assist in developing regulatory strategies that align with business goals and regulatory requirements, ensuring timely market access.
Compliance Monitoring: Ensure products comply with FDA, ISO 13485, EU MDR, and other applicable regulatory standards and guidance. Monitor changes in regulations and assess their impact on current products and processes.
Labeling and Documentation: Review and approve labeling, marketing materials, and packaging to ensure regulatory compliance. Maintain regulatory documentation for each product.
Cross-functional Collaboration: Work closely with quality, R&D, engineering, and manufacturing teams to ensure products meet regulatory requirements at all stages of development and commercialization.
Audits and Inspections: Support internal and external audits, including FDA inspections and ISO audits, by preparing documentation, answering regulatory questions, and implementing corrective actions as needed.
Post-market Surveillance: Assist with post-market activities, such as adverse event reporting, recalls, and field corrections, as required by regulatory bodies.

Qualifications:
Education: Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or a related field.
Experience: 3+ years of regulatory affairs experience in the medical device industry.
Regulatory Knowledge: In-depth understanding of FDA regulations (21 CFR Part 820), ISO 13485, and EU MDR. Familiarity with global regulatory requirements and submission processes.
Technical Skills: Experience with electronic submission systems (e.g., eCTD, CDER Direct) and regulatory documentation management.
Communication Skills: Strong written and verbal communication skills for clear interactions with regulatory bodies, internal teams, and external partners.