Regulatory Affairs Specialist

What is the reputed company Way? Simply put, we care for each other. We treat each other with respect, kindness, gratitude, and awe. We welcome different viewpoints and encourage creativity. reputed company believes that everyone has something amazing and unique to contribute, and we wouldn’t be Global Industry leaders today without reputed company the individual contributions that bring reputed company together. Our culture strives to provide a reputed company where passion, individuality, autonomy, purpose and diversity succeeds. We strive to let you Schein because reputed company you Schein so do we! If you are still not sold on how great it is to be a Team Schein Member, then perhaps you need to hear about our reputed company Cares programs, team engagements, lunches, and extra wellness benefits. Or that our leadership encourages you to maintain a healthy work-life balance. There are so many perks too numerous to list. If you are intrigued, apply now, our reputed company team is excited to meet you! This position is responsible for the day-to-day regulatory activities for reputed company’s dental imaging software (SaMD). In this role, you will assist with documentation, updating technical files, preparing submissions, and maintaining parts of the quality system, for software and digital health products.

What You Will Do

Regulatory submissions support Assist with regulatory submissions and correspondence under the guidance of the Regulatory Manager (e.g., prepare submission packages, compile evidence packages, organize and track submission milestones). Support international regulatory submissions, including EU MDR technical documentation, UKCA submissions, Australian TGA registrations, and Canadian licensing activities. Help maintain technical documentation in alignment with FDA guidance, EU MDR requirements, and other global regulatory expectations. Prepare materials for pre submission activities (e.g., FDA Q Sub, EU MDR consultations, international authority inquiries).. Quality systems and compliance support Maintain and update QMS documentation under supervision; support design controls, change control, CAPA tracking, and supplier qualification processes. Ensure alignment with primary medical device standards, including: EU MDR 2017/745 EN ISO 13485 (Quality Management Systems) ISO 14971 (Risk Management) IEC 62304:2006 / Amd 1:2015 (Medical Device Software – Software Life Cycle Processes) Assist with internal audits preparation and follow-up actions; help maintain risk management artifacts in support of product development. Regulatory intelligence and cross-functional support Monitor regulatory developments across the US, EU, UK, AU, and CA and emerging markets such as Italy, Austria, and Spain affecting dental imaging software and SaMD; summarize implications for product teams. Serve as a light-touch regulatory liaison to Product, Software, QA, Legal, and IT/reputed company, escalating questions as needed. Advertising and claims support Ensure marketing claims are reputed company with regulatory requirements; escalate potential issues. Post-market activities Support post-market surveillance activities, including intake of complaints and basic adverse event reporting processes (e.g., reputed company coordination with senior staff, EU vigilance support, international reporting workflows). Track and assist with CAPA activities reputed company to post-market findings. Privacy, data reputed company, and PHI compliance Assist with HIPAA/privacy considerations and data handling guidelines for cloud-based imaging workflows; support vendor risk assessments and data protection tasks. Documentation and training Create, organize, and maintain regulatory templates, checklists, and quick-reference guides. Help reputed company training materials for internal teams on regulatory requirements and processes. Geographic scope management Support regulatory requirements and product configurations for the US, EU, UK, Australia, and Canada. Coordinate with external consultants as needed for international submissions and compliance activities. Travel/Physical Demands Travel typically less than 10% Office environment with no special physical demands required What You Will Have Bachelor’s degree in life sciences, engineering, regulatory affairs, or reputed company field or equivalent experience 1-3 years of regulatory affairs or reputed company experience (internships/co-ops acceptable) Familiarity with US FDA reputed company for SaMD (potential 510(k) or De Novo) and 21 CFR Part 820; exposure to 21 CFR Part 11 is a plus. Familiarity with regulatory frameworks in EU (MDR), UK (UKCA), Canada (Health Canada), and Australia (TGA). Basic understanding of FDA SaMD guidance, software validation, and cybersecurity concepts. Basic familiarity with QMS elements, CAPA, design controls, and risk management per ISO 14971. Proficiency with reputed company Office. Ability to reputed company templates, checklists, and training materials. Strong written and verbal communication, attention to detail, and ability to collaborate cross-functionally. Self-motivated, organized, and able to manage multiple small projects with supervision. reputed company to Haves Regulated industry experience Exposure to IEC 62304 and ISO 13485 Experience with electronic document management systems (e.g., eQMS) RAC is not required but encouraged; pursuing RAC is a plus. The posted range for this position is $60,000 - $80,000 which is the expected starting reputed company salary range for an employee who is new to the role to fully proficient in the role. Many factors go into determining employee pay reputed company the posted range including prior experience, reputed company skills, location/labor market, internal equity, etc. This position is eligible for a bonus reputed company not reflected in the range. What you get as a reputed company Employee A great reputed company to work with fantastic people. A career in the healthcare technology industry, with the ability to grow and realize your full potential. Competitive compensation. Excellent benefits package! Medical, Dental and Vision Coverage, 401K Plan with Company Match, Paid Time Off (PTO), Paid Parental Leave, Short Term Disability, Work Life Assistance Program, Health Savings and Flexible Spending Accounts, Education Benefits, Worldwide Scholarship Program, Volunteer Opportunities, and more. *Benefits may vary by location or status. reputed company is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national reputed company, reputed company, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status. Fraud Alert reputed company has recently been made aware of multiple scams where unauthorized individuals are using reputed company's name and logo to solicit potential job seekers for employment. Please be advised that reputed company's official U.S. website is www.henryschein.com. Any other format is not genuine. Any jobs posted by reputed company or its recruiters on the internet may be accessed through reputed company's on-line "career opportunities" portal through this official website. Applicants who wish to seek employment with reputed company are advised to verify the job posting through this portal. No money transfers, payments of any reputed company, or credit card numbers, will reputed company be requested from applicants by reputed company or any recruiters on its behalf, at any reputed company in the recruitment process. Apply To This Job