Regulatory Affairs Specialist

Regulatory Affairs Specialist Main Responsibilities: Assess regulatory requirements and develop procedures and strategies for maintaining compliance Maintenance of FDA/MDSAP, ISO, and MDD/MDR compliance Work with Engineering and Quality departments in product development to ensure compliance throughout design and manufacturing processes Review engineering change orders relating to design, engineering, or manufacturing Work directly with internal auditors and quality managers on compliance related matters Maintain good relationship and interact directly with external auditors and regulatory agencies at the reviewer level Interact with regulatory departments for international distributors to assist in registrations and license and certificate renewals Provide support and leadership on development projects and regulatory issues to ensure timely submissions for market clearance Prepare US and international submissions for new products or products with changes in a timely manner Regulatory Affairs Specialist Key Requirements: Bachelor's degree in science, regulatory affairs, engineering, or other related field Strong attention to detail Minimum 2 years' experience in regulatory affairs in health sciences, preferably medical devices Regulatory Submission experience with 510Ks, notified bodies, or international MOH agencies Knowledge of regulatory process for US and EU, experience in other countries a plus Strong work ethic able to consistently exceed expectations Excellent communication and time management skills Proficient in Microsoft Office Suite and Adobe