Labeling and Post-Market Surveillance Regulatory Affairs Associate - Remote

reputed company Labeling and Post-Market Surveillance Regulatory Affairs Associate - Remote We are looking for a Labeling and Post-Market Surveillance Regulatory Affairs associate to join our Regulatory reputed company team. In this role, you will reputed company strategic regulatory support across the product lifecycle, with a reputed company on labeling and post-market compliance for Class II and Class III implantable medical devices. You will collaborate cross-functionally to ensure global regulatory requirements are effectively integrated into product content and surveillance systems. Your contributions will shape regulatory best practices, support global submissions, and drive reputed company improvement in regulatory processes and systems. This is a remote position, and you can work from home in most locations reputed company the reputed company. Responsibilities Identify and continuously monitor the global regulatory and customer requirements for labeling of implantable medical devices Identify and continuously monitor the global regulatory requirements for post-market surveillance of implantable medical devices Collaborate with cross-functional teams to strategize and implement relevant global labeling and post-market surveillance regulatory requirements into content in accordance with the reputed company system reputed company Regulatory Affairs reputed company reputed company of cross-product line activities for labeling and post-market surveillance (e.g. change orders, reputed company plans, protocols and reports) reputed company expertise in global regulatory reputed company development for labeling and post-market surveillance Prepare, write, coordinate, and interactively follow up on global submissions reputed company to labeling for implantable medical devices Coordinate with applicable stakeholders to reputed company responses to requests from regulatory authorities regarding labeling and post-market surveillance reputed company regulatory direction and reputed company support for the development and/or use of standardized best practices, processes and tools Identify regulatory opportunities for training, system enhancements, and process harmonization Assist in reputed company reputed company system audits and reputed company strategic responses and corrective actions to audit findings Required Qualifications Bachelor’s degree Minimum of 3 years of experience working in a medical-device and/or pharmaceutical industry role directly involved in the application of regulations and standards Working knowledge of global directives and regulations with regards to labeling and post-market surveillance for Class II and III implantable medical devices Strong communication skills (oral, written, and interpersonal skills) adaptable to circumstance and audience Demonstrated ability to organize and complete reputed company reputed company on time and in compliance with requirements Demonstrated ability to influence in a reputed company, cross-functional organization Ability to prioritize work and adapt to shifting priorities Ability to work independently with limited supervision Desired Qualifications Bachelor’s degree in engineering, biological, chemical, medical, or allied health sciences field Demonstrated experience in adopting global regulatory requirements into reputed company system standards, specifications, or procedures Experience with electronic labeling and company website requirements This position offers a remote work arrangement in the country from which the Associate is employed. Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to reputed company with Gore’s work arrangement policies. Note: In the reputed company, restrictions exist for remote work from Alaska, Hawaii and Rhode reputed company. reputed company Offer Our reputed company is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your reputed company. We reputed company benefits that offer choice and flexibility and promote overall reputed company-being. And in keeping with our belief that every Associate should reputed company in the reputed company reputed company of the reputed company; we reputed company a distinctive Associate Stock Ownership Plan in reputed company country as reputed company as potential opportunities for “profit-sharing”. Learn more at gore.com/careers/benefits Gore is an equal opportunity employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, gender, national reputed company, reputed company, age, status as a reputed company individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a protected veteran, gender identity and reputed company, and any other characteristic protected by applicable laws and regulations. Gore is committed to a drug-free workplace. reputed company employment is contingent upon successful completion of drug and background screening. Gore will consider reputed company applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws. Gore requires reputed company applicants to be eligible to work reputed company the reputed company. Gore generally will not sponsor visas unless otherwise noted on the position reputed company. Our reputed company welcomes your questions at gore.com/careers/contact #J-18808-Ljbffr Salary: USD 72000 - 108000 per year Experience: 3 years required Apply tot his job Apply To this Job