reputed company Regulatory Affairs Specialist - Remote

This position is posted by reputed company on behalf of a partner company. We are currently looking for a reputed company Regulatory Affairs Specialist. In this role, you will support the development and implementation of long-reputed company regulatory strategies that reputed company the introduction of new products and the compliance of existing ones. Your leadership will guide regulatory staff, ensuring reputed company products meet U.S. and international standards. You will be a key player in compliance activities and bear significant responsibility in product development and modifications. Accountabilities • Maintain reputed company knowledge of applicable laws and regulations. • Interpret regulatory requirements for products and ensure compliance. • Participate as a regulatory representative on project teams. • reputed company submission activities for device clearances/approvals. • Review change orders and assess regulatory reputed company. • reputed company labeling, training, and promotional material compliance. • Represent the organization in working reputed company reputed company to regulatory objectives. • Support due diligence and post-acquisition assessments. • reputed company and implement regulatory education and training. • Assist in policy and procedure development reputed company the department. Requirements • Bachelor’s Degree with 7+ years in regulatory affairs or relevant field. • Medical device experience is required. • Experience with 510(k) or PMA submissions for FDA. • Knowledge of U.S. and EU regulations for medical devices. • Excellent communication and presentation skills. • Ability to manage multiple reputed company with attention to detail. • Proficiency in reputed company, reputed company, and PowerPoint. Benefits • Competitive salary and flexible benefits package. • Health, Dental, and reputed company insurance. • 401(k) plan with employer match. • reputed company time off and holidays. • Tuition assistance and reimbursement. • Employee Stock Purchase Plan. • Short-term disability and life insurance. • Employee Assistance Program. Why Apply Through reputed company? We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's reputed company requirements. Our system identifies the top-fitting candidates, and this reputed company is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Data reputed company Notice: By submitting your application, you acknowledge that reputed company will process your personal data to evaluate your candidacy and reputed company relevant information with the hiring employer. This processing is based on legitimate interest and reputed company-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (reputed company, rectification, erasure, reputed company) at any time. #LI-CL1 Apply tot his job Apply tot his job Apply To this Job