Regulatory Affairs Specialist

Responsibilities

The Regulatory Affairs Specialist is responsible for identifying, evaluating, and ensuring compliance with all applicable laws, regulations, and standards.

Market Analysis and Compliance

The Regulatory Affairs Specialist shall also conduct reviews of all and all future target markets to ensure knowledge and fulfillment of establishment registration, device licensing, surveillance, adverse event and corrective action reporting, translation, product standards, and all other requirements necessary to support import, sales, distribution, installation, and support in all chosen distribution markets.

Duties

• Remain aware of new or updated regulations, laws, standards and other official enactments that may apply to the company.
• Provide detailed analysis, official recommendations, and gap analyses for new or revised standards and regulations.
• Manage medical device adverse and field corrective actions reports and recall notifications.
• Ensure adequate compliance schemes associated with all regulatory compliance systems, as required by law.
• Author and maintain all regulatory product clearance submissions and submission materials.
• Submit Establishment and Device registration applications. Prepare IDE, 510(k), PMA, CE Mark, and other related regulatory filings.
• Represent the company as formal escort or other role in external audits and other regulatory agency interactions.
• Obtain and maintain company ISO and CE Certification, as appropriate.
• Develop, document, and implement regulatory strategy for new technologies and product modifications.
• Interface with FDA and other regulatory agencies regarding regulatory submission strategy and approval reviews, as per company marketing plans.
• Establish and implement necessary policies, procedures, templates related to Regulatory Affairs.
• Ensure completion of appropriate systems, mechanisms, and record-keeping.
• Prepare and present Regulatory content for Management Review.

Qualifications

Minimum educational, training, and experience qualifications:

• Bachelor’s Degree in medical, clinical, engineering or scientific discipline
• 5-10 years relevant experience in a similar position in a regulated medical device manufacturing environment.
• Excellent public speaking, professional writing, typing, and general office application skills are essential for substantial cross-organizational interaction and facilitation, as well as process and record generation.
• Excellent English written and verbal communication skills are essential.
• Experience with EU MDR, ISO13485, FDA 510(k), PMA, IEC 60601, IEC 62304 required. NMPA experience preferred.
• Experience with complex medical devices and capital equipment preferred. Radiation oncology experience is a big plus.
• Experience with Post-Market Surveillance and Clinical Evaluation preferred.

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