Regulatory Affairs Specialist

Regulatory Affairs Specialist - Medical Devices $110k - $120k and 8% NO CTCWe are seeking an experienced Regulatory Affairs Specialist to join a dynamic team in the medical device industry. Working knowledge of FDA 510(k) submissions is a must. This role offers an exciting opportunity to contribute to regulatory compliance and support a company committed to innovation in healthcare solutions. About the Role:As a Regulatory Affairs Specialist, you will play a critical role in assembling and managing regulatory submissions, maintaining compliance with global regulations, and supporting cross-functional teams. Your expertise will ensure that regulatory policies and procedures align with industry standards and drive successful product approvals. Key Responsibilities:Prepare, review, and assemble regulatory documents for submissions in compliance with relevant guidelines. Manage information for U.S. and international submissions, including device master files, technical files, annual reports, and amendments. Maintain and update regulatory databases and submission records. Communicate with regulatory agencies to clarify submission requirements and ensure compliance. Review and recommend regulatory policies, SOPs, and protocols to maintain adherence to FDA and international standards. Stay updated on regulatory rules, guidance documents, and standards, and provide interpretive assistance. Write or revise SOPs, work instructions, and policies to align with evolving regulatory requirements. Participate in audits, product recalls, and regulatory training programs. Collaborate with internal teams to develop and manage regulatory timelines and responses. Qualifications & Requirements:8+ years of experience in the medical device industry. Bachelor's degree in a related field or equivalent combination of education and experience. Strong knowledge of 21 CFR, FDA guidelines, GMPs, and international regulatory standards. Proficiency in MS Word, Excel, and PowerPoint. Excellent verbal and written communication skills in English. Strong organizational, interpretive, and interpersonal skills. Ability to manage multiple tasks and work effectively in cross-functional teams. Attention to detail and commitment to quality.

Created: 2025-01-09