Specialist I, Regulatory Affairs - Medical Device

Position Summary:

• Assist in executing regulatory compliance programs; coordinate required training.
• Develop increasing working knowledge of regulations, standards, company SOPs and tools.
• Assist in executing timely and effective global reporting of medical devices malfunctions and adverse events.
• Assist cross functional teams in timely and effective closure of RA corrective and preventive actions (CAPAs).
• Assist in tracking standards, regulations and all applicable requirements.
• Assist in executing global field corrective actions/recalls.
• Responsibilities may include pre-market and/or post-market as defined by the company.
• Assist in efforts to prepare and submit regulatory submittals for market clearance, licensing, registration and legalization.
• Other duties as assigned.
• Assist in authoring trending reports for pre- and post-market regulatory activities.
• Assist in efforts to ensure the company is properly registered and in compliance with applicable federal, state, local and international regulations (ex. Food and Drug Administration (FDA) for which Regulatory Affairs (RA) is responsible.
• Accurately and completely document regulatory and quality activities as required.
• Assist in interactions regarding regulatory affairs with all functional areas of the company as required including senior management.
• Assist in conducting final Level 1 case reviews prior to complaint closure.

• Must possess a strong willingness to comply with regulations and procedures and provide transparency to management regarding all work related issues.
• Bachelors degree (Science preferred) or equivalent applicable experience.
• Good written and verbal communication skills. Must be self-motivated and have the ability to work with minimal supervision; must also be able to work as part of a team.
• Minimum of one (1) to two (2) years in Regulatory Affair or combination experience in regulatory affairs, clinical affairs, and quality assurance RASI.
• Experience and knowledge regarding global premarket clearance activities preferred.
• Strong computer skills required: MS Office, ability to use an enterprise resource planning system (ERP) and other regulatory software tools.
• Must possess awareness of the requirements of relevant federal and international regulations such as those issued by the Food and Drug Administration (FDA) as the Quality System Regulations (QSR) and applicable standards issued by the International Standards Organization (ISO).
• Experience and knowledge regarding global post market activities preferred.
• Must possess demonstrated experience working in an FDA regulated environment such as medical device or pharmaceutical.