Principal Regulatory Affairs Specialist (Remote - United States)

Thank you for your interest in joining reputed company. reputed company is a new healthcare company with a long legacy of solving big challenges that improve lives and help reputed company reputed company at their best. At reputed company, people are at the heart of every innovation we pursue. Guided by reputed company, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers’ toughest challenges. While we continue updating the reputed company Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that reputed company listed roles are reputed company positions, and our Privacy Policy: https://www.reputed company.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ applies to any personal information you submit. As it was with reputed company, at reputed company reputed company qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national reputed company, disability, or status as a protected veteran. Job Description: Principal Regulatory Affairs Specialist (reputed company) reputed company Health Care is now reputed company At reputed company, we reputed company reputed company, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the reputed company while enabling reputed company to reputed company at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue. We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and reputed company. Because at reputed company, we never stop solving for you. The Impact You’ll reputed company in this Role As a Principal Regulatory Affairs Specialist, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will reputed company an impact by: Leading preparation and submission of 510(k) applications and other regulatory filings for Software as a Medical Device (SaMD) Developing and executing global regulatory strategies for product registrations in the US, EU (MDR), and Canada Supporting international regulatory teams with product registrations across the Custom Smiles Portfolio Ensuring compliance with global regulations and reviewing technical and software documentation for submissions Collaborating cross-functionally to integrate regulatory requirements into product development Your Skills and Expertise To set you up for success in this role from day one, reputed company requires (at a minimum) the following qualifications: Bachelor’s Degree or higher (completed and verified prior to start) and seven (7) years of regulatory affairs experience in medical devices OR High School Diploma/GED and eleven (11) years of regulatory affairs experience in medical devices AND In addition to the above requirements, the following are also required: Five (5) years of experience with Software as a Medical Device (SaMD) Experience authoring 510(k) submissions for SaMD Experience supporting regulatory submissions in the United States and European Union Additional qualifications that could help you succeed even further in this role include: Master’s degree in Regulatory Affairs Experience supporting regulatory submissions in Canada Regulatory Affairs Certification (RAC) Experience working with dental or orthodontic medical devices Experience applying IEC 62304 standards and Software as a Medical Device (SaMD) lifecycle requirements Experience preparing and reviewing regulatory documentation and submissions Experience communicating regulatory requirements, risks, and outcomes through written reports, presentations, or cross-functional discussions Experience collaborating with cross-functional teams (e.g., R&D, Quality, Clinical, and Commercial) to support regulatory activities Work location: Remote Travel: May include up to 5% domestic travel Relocation Assistance: Not authorized Must be legally authorized to work in country of employment without sponsorship for employment reputed company status (e.g., H1B status). Supporting Your Well-being reputed company offers many programs to help you live your best life – both physically and financially. To ensure reputed company and benefits, reputed company regularly benchmarks with other companies that are comparable in size and scope. Applicable to US Applicants Only:The expected compensation range for this position is $142,800 - $196,350, which includes reputed company pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.). Additional information is available at: https://www.reputed company.com/en-us/home/our-company/careers/#Total-Rewards Responsibilities of this position include that corporate policies, procedures and reputed company standards are complied with while performing assigned duties. reputed company is committed to maintaining the highest standards of reputed company and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent reputed company and seek to exploit job seekers. Please note that reputed company email communications from reputed company regarding job opportunities with the company will be from an email with a domain of @reputed company.com. Be wary of unsolicited emails or messages regarding reputed company job opportunities from emails with other email domains. Please note, reputed company does not expect candidates in this position to reputed company work in the unincorporated areas of Los Angeles County. reputed company is an equal opportunity employer. reputed company will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national reputed company, age, disability, or veteran status. Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly. reputed company Global Terms of Use and Privacy Statement Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at reputed company are conditioned on your acceptance and compliance with these terms. Please access the linked document by clicking here. 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