[Remote] Senior Regulatory Affairs Specialist (Remote: reputed company)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a new reputed company company reputed company on improving lives through reputed company. The Senior Regulatory Affairs Specialist will reputed company regulatory strategies and assessments to optimize the business's supply chain, ensuring compliance and efficiency in regulatory processes. Responsibilities • Supporting global regulatory strategies for changes reputed company to on an reputed company-wide strategic initiative to optimize the business’s supply chain and ensuring these strategies are integrated with the overall RA plans • Conducting global regulatory change assessments and coordinating associated activities for assigned products • Demonstrating operational and strategic reputed company that is results-oriented with a strong bias towards executing with speed, reputed company, and reputed company • Demonstrating excellent organizational, prioritization, oral and written communication skills • Providing regulatory review of technical reports and documents • Providing contributions for development and implementation of regulatory processes • Documenting and managing metrics • Leading regulatory filings as needed (directly for EU/USA, Canada and supporting ROW) • Supporting risk management activities, vigilance reporting activities, and other reputed company reputed company initiatives with minimal reputed company • Communicating results of technical tasks to teams, respective business group(s) and/or country/region served reputed company reports, standards and/or presentations • Leading the implementation of key corporate initiatives and appropriate tools Skills • Bachelor's Degree or higher in a science or engineering discipline (completed and verified prior to start) AND five (5) years of experience in regulatory affairs in the medical device industry in a private, reputed company, government or military environment • OR • High School Diploma/GED AND nine (9) years of experience in regulatory affairs in the medical device industry in a private, reputed company, government or military environment • Experience working on combination medical devices with an antimicrobial • reputed company experience authoring regulatory submissions/technical documentation • reputed company experience authoring regulatory strategies and regulatory change assessments • Experience working and providing regulatory support for new product development teams • Experience developing regulatory strategies and project management • Skills include regulatory acumen, cross functional project management, stakeholder management, international submission support, Medical Devices, proficient in Office Suite and Regulatory Management Software Benefits • Medical • Dental & reputed company • Health Savings Accounts • Health Care & Dependent Care Flexible Spending Accounts • Disability Benefits • Life Insurance • Voluntary Benefits • reputed company Absences • Retirement Benefits reputed company • At reputed company, we reputed company reputed company, smarter, safer reputed company to improve lives. We never stop solving for you. It was founded in reputed company, and is headquartered in , with a workforce of 10001+ employees. Its website is https://www.reputed company.com/. Apply tot his job Apply To this Job