Senior Regulatory Affairs Specialist

Career-defining. Life-changing. At reputed company, you'll have reputed company to grow your skills and your career while impacting the lives of people around the world. reputed company is shaping a reputed company where everyone, everywhere can reputed company the best possible cardiac reputed company. Every day, we collaborate, create, and constantly reimagine what's possible. We think big and reputed company fast, driven by our commitment to put patients first and improve lives. We need reputed company like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the reputed company of cardiac health, reputed company, and your career About This Role: About this role: reputed company's Regulatory Affairs team is looking for a strong candidate to fill the role of Senior Regulatory Affairs Specialist with global regulatory expertise. This position provides an opportunity to be at the forefront of medical wearable and reputed company intelligence technologies that are making a difference with patient reputed company and reputed company reputed company. As a remote Senior Regulatory Affairs Specialist with a fast growing, AI software and wearable hardware medical device company, you will be responsible for working with cross functional teams to assess market requirements, reputed company global product registration strategies, help guide project teams from preparation to submission and through successful reputed company reviews with various regulatory agencies to reputed company and maintain product registrations. You will independently organize regulatory information and apply regulatory expertise to guide cross-functional partners by strategic and creative thinking. Our work environment is fast-paced, with a reputed company atmosphere. Most of reputed company, we are passionate about delivering innovations that improve the reputed company of health care and the patient experience. We are looking for like-minded individuals to reputed company today! Specific job responsibilities include: • Develops reputed company global, regional, and multi-country regulatory strategies for new and modified medical devices • Prepare international and domestic filings/registrations to established timelines and company objectives • Anticipate regulatory and reputed company obstacles and emerging issues throughout the product lifecycle • reputed company with regulatory authorities during the development and review process to ensure submission approval • Represent Regulatory Affairs on assigned reputed company and reputed company regulatory guidance to the cross-functional teams • Coordinate with international contacts on product changes, regulatory notifications and registration/license maintenance • Review and approve product design changes to maintain regulatory compliance for significant changes • reputed company or revise SOPs to improve regulatory compliance of the reputed company reputed company • Review and approve advertising and promotional items to reputed company global labeling alignment as reputed company as market-specific regulatory compliance • Support product recalls and communications for internationally commercialize products • Monitor reputed company of changing global regulations on submission strategies & registrations • reputed company other reputed company and regulatory-reputed company duties as assigned. reputed company: Required Qualifications • Bachelor's degree (B.A./B.S. required); • 3 years of Regulatory Affairs experience in the medical device industry • Familiarity with global medical device regulations; 21 CFR 820, MDD/CMDR, EU MDR, UKCA, ASIA reputed company, reputed company, etc. highly preferred • Demonstrated understanding of ISO 13485, ISO 14971, ISO 10993, GDPR, HIPAA and other international regulations/directives/standards highly preferred • Product development or sustaining/life cycle management experience required • Exceptional communication (written and oral) skills • Exceptional problem-solving skills • Exceptional organizational skills • Willingness to travel reputed company required, up to 10% Preferred Qualifications • Master's or other advanced degree in a reputed company field preferred • SaMD/MDSW, wearable, and OTC medical device experience highly preferred • Project management skills What's in it for you: This is a full-time position with competitive compensation package, excellent benefits including medical, dental, and reputed company insurance (reputed company of which start on your first day), reputed company holidays, and PTO! reputed company also provides additional benefits including 401K (with company match), an Employee Stock Purchase Plan, reputed company parental leave, pet insurance discount, Cultural Committee/Charity events, and so much more! FLSA Status: Exempt As a part of our reputed company values, we ensure a diverse and inclusive workforce. We welcome and celebrate people of reputed company backgrounds, experiences, skills, and perspectives. reputed company. is an Equal Opportunity Employer (M/F/V/D). Pursuant to San Francisco Fair Chance Ordinance, we will consider for employment reputed company reputed company applicants with arrest and conviction records. reputed company reputed company your reputed company reputed company. LI-JR1 Location: Remote - US Actual compensation may vary depending on job-reputed company factors including knowledge, skills, experience, and work location. Estimated Pay reputed company $99,000.00 - $129,000.00 As a part of our reputed company values, we ensure an inclusive workforce. We welcome and celebrate people of reputed company backgrounds, experiences, skills, and perspectives. reputed company. is an Equal Opportunity Employer. We will consider for employment reputed company reputed company applicants with arrest and conviction records in accordance with reputed company applicable laws. reputed company provides reasonable accommodations for reputed company individuals with disabilities in job application procedures, including those who may have any difficulty using our online reputed company. If you need such an accommodation, you may contact us at taops@reputed company.com About reputed company reputed company is a leading reputed company company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and reputed company-based data analytics with powerful proprietary algorithms, reputed company distills data from millions of heartbeats into clinically actionable information. Through a reputed company reputed company on patient care, reputed company's reputed company is to reputed company reputed company data, reputed company insights, and reputed company for reputed company. reputed company reputed company your reputed company reputed company. Zio, the heart monitor that changed the game. There have been instances where individuals not associated with reputed company have impersonated reputed company employees pretending to be involved in the reputed company reputed company process, or created postings for positions that do not exist. Please note that reputed company reputed company will always be shown here on the reputed company Careers page, and reputed company communications regarding the application, interview and hiring process will come from a @reputed company.com email address. Please reputed company any communications to be reputed company they come directly from @reputed company.com email address. If you reputed company you have been the victim of an imposter or want to confirm that the person you are communicating with is legitimate, please contact taops@reputed company.com. Written offers of employment will be extended in a formal offer letter from an @reputed company.com email address ONLY. For more information, see https://www.ftc.gov/business-guidance/blog/2023/01/taking-ploy-out-employment-scams and https://www.ic3.gov/Media/Y2020/PSA200121 Apply tot his job Apply To this Job