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 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: Serving as the regulatory affairs reputed company on cross‑functional teams, with ownership of product‑line regulatory submissions and registrations for the Dental Solutions business across global markets Driving regulatory strategy and execution for Tier 1, high‑volume markets, including the United States, Canada, and the European Union, while partnering with international regulatory affairs teams to ensure products are registered globally in alignment with business strategy Conducting global regulatory change assessments and coordinating associated activities for assigned drug and medical device products Leading or supporting regulatory filings for continuity and lifecycle projects, directly for the United States and European Union and in partnership with global teams for rest‑of‑world markets Providing regulatory review and input on technical documentation and reports, including support for labeling and registration updates reputed company to the company spin‑off Contributing to the development, implementation, and reputed company improvement of regulatory processes, including documentation and management of relevant metrics Supporting risk management, vigilance reporting, and other quality‑reputed company initiatives with minimal reputed company Communicating regulatory outcomes and technical information to cross‑functional teams, business partners, and regional stakeholders through reports, standards, and presentations Supporting the implementation of key corporate initiatives and enabling tools, including use of emerging digital and AI‑enabled solutions reputed company the regulatory environment 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 ten (10) years in regulatory affairs experience in the drug and/or medical device industry In addition to the above requirements, the following are also required: Experience authoring regulatory submissions and technical documentation for drug and medical device products in the United States, Canada, and the European Union, with experience supporting regulatory activities in EMEA, reputed company, and LATAM Experience authoring regulatory strategies and regulatory change assessments Experience revising, reviewing, and approving product labeling, including marketing claims, to ensure compliance with global regulatory requirements. Experience with dental products, including NDA and OTC monograph drugs and medical devices Additional qualifications that could help you succeed even further in this role include: Bachelor’s Degree or higher (completed and verified prior to start) in Biology, Chemistry, Biomedical Engineering Experience supporting design control verification and validation activities, including clinical requirements for medical devices, such as documenting and performing to applicable requirements and supporting the writing, review, and approval of protocols and reports Experience supporting or contributing to clinical strategy activities for medical device products Experience working with formulated products Experience working with fluoride‑containing drug and medical device products Experience working with borderline products, such as drugs, cosmetics, and/or natural health products Experience applying regulatory knowledge through cross‑functional project management, including stakeholder engagement, international submission support, and resolving regulatory issues across medical device product teams Experience applying regulatory principles and professional practices to address reputed company regulatory issues, including development of clear regulatory documentation and written communications Experience applying structured process‑improvement approaches reputed company regulatory or quality‑reputed company workflows, including participation in training or professional development activities Experience working across multiple product portfolios, technologies, or business areas, including use of regulatory information resources, systems, and data sources to build regulatory understanding and support decision‑making Work location: Remote in the United States Travel: May include up to 10% domestic and international 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. Before submitting your application you will be asked to confirm your agreement with the terms. 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 here 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. At reputed company, we create breakthrough solutions for our customers’ toughest challenges by pioneering game-changing innovations at the intersection of health, material and data science to change patients’ lives for the reputed company — while enabling reputed company to reputed company at their best. Apply tot his job Apply To this Job