Lead Regulatory Affairs Specialist - remote

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Principal Regulatory Affairs Specialist - REMOTE. In this role, you will have a significant impact on ensuring that healthcare products comply with regulatory standards. You will lead regulatory strategies for product introduction and maintenance, mentor junior colleagues, and be responsible for navigating regulatory pathways. Your expertise will play a crucial role in maintaining compliance while driving innovation in healthcare solutions. Your contributions will help shape the future of medical advancements and improve healthcare access globally. Accountabilities • Maintain knowledge of regulatory laws and industry standards. • Interpret regulatory requirements for product compliance. • Provide guidance on FDA and international product registration. • Lead submission activities for regulatory approvals. • Review product change orders for regulatory impact. • Evaluate promotional and advertising materials for compliance. • Collaborate in cross-departmental regulatory initiatives. • Support acquisitions through compliance assessments. • Develop regulatory training programs for staff. • Ensure adherence to Quality System compliance. Requirements • Bachelor’s Degree with 7+ years of experience in regulatory affairs. • Advanced degree with a minimum of 5 years' related experience. • Experience with 510(k) and PMA submissions. • In-depth knowledge of U.S. and EU regulations. • Proficient in Microsoft Office (Word, Excel, PowerPoint). • Excellent communication and presentation skills. • Strong organizational and project management capabilities. • Ability to work under ambiguity and manage multiple projects. Benefits • Competitive salary and flexible benefits package. • Health, dental, and vision insurance. • Health Savings Account and Flexible Spending Accounts. • Life insurance and long-term disability coverage. • Tuition assistance and reimbursement programs. • 401(k) plan with employer contribution and match. • Paid time off and paid holidays. • Employee Stock Purchase Plan and Incentive plans. Why Apply Through Jobgether? We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist 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 Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time. #LI-CL1 Apply tot his job