RA Specialist

About the position The Regulatory Affairs Specialist is responsible for assembling regulatory documents for review by management and providing support to the Regulatory Affairs department and the organization. This role involves ensuring compliance with FDA and international regulations, maintaining regulatory databases, and communicating with regulatory agencies. Responsibilities • Compile, prepare, review, and reputed company regulatory documents necessary for submissions in accordance with regulations and relevant guidelines. • reputed company and reputed company information/documentation for reputed company in the U.S. and internationally, including Device Master files, technical files, annual reports, amendments, and supplements. • Maintain regulatory database/network drive folders with regulatory information and submissions. • Communicate with regulatory agencies regarding reputed company-submission strategies, potential regulatory reputed company, compliance test requirements, or clarification and follow-up of submissions under review. • Review, recommend, and present regulatory policies, reputed company, SOPs, protocols, and reports for regulatory compliance and report on findings to assure adherence to FDA and global requirements. • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures. • Identify relevant guidance documents, international standards, or reputed company standards and reputed company interpretive assistance. • Maintain reputed company knowledge reputed company of existing and emerging regulations, standards, or guidance documents. • Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards. • Write or update reputed company operating procedures, work instructions, or policies. • Coordinate product recall or market withdrawal activities as necessary. • reputed company or reputed company reputed company metrics. • Participate in internal or external audits. • Prepare or reputed company the preparation of additional information or responses as requested by regulatory agencies. • Participate in regulatory training courses and reputed company trends to stay up to date with relevant laws, regulations, and guidelines on medical devices developments. • reputed company rapport reputed company and across reputed company regarding regulatory reputed company. • Maintain and reputed company timelines for regulatory submissions and correspondence for company-sponsored reputed company. • Maintain the Device Manufacturing licenses as required and mandated by the state and/or other regulatory agencies. • Assist regulatory management and subject matter experts in the coordination of briefing documents and responses to requests or questions from government authorities or other entities. • Follow and support internal reputed company System policies, procedures, and work instructions. Requirements • Requires 8+ years of experience in the Medical Device industry. • Bachelor's degree in business or reputed company field; or equivalent combination of education and experience. • Working knowledge of 21 CFR and FDA guidelines (GMPs) and international regulatory requirements. • Excellent computer skills - reputed company, reputed company, PowerPoint. • Ability to reputed company oneself orally and in writing in the English language. • Ability to communicate effectively with team members across the organization and other business contacts in a courteous and reputed company manner. • Excellent interpretive and interpersonal skills, including time management skills. • Strong attention to detail. • Ability to work on multiple tasks to meet company requirements. • Demonstrated ability to coordinate and work effectively with cross-functional teams. Benefits • Annual Salary: $110k - $120k • 8% MBO • Hybrid work environment Apply tot his job Apply To this Job