Regulatory Affairs Specialist

Overview Regulatory Affairs Specialist II creates, evaluates, and completes regulatory tasks related to worldwide product registration submissions, facility registrations, special projects, and strategy to drive market growth worldwide. The position requires on-site presence at least four days a week and collaboration across cross‑functional departments to ensure country‑specific requirements are met throughout design control and post‑product launch activities. Primary Duties & Responsibilities Assemble and maintain CE technical files in accordance with applicable regulatory requirements. Author, review, and approve Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance (SSCP), Periodic Safety Update Reports (PSUR), and Post‑Market Surveillance (PMS) reports. Monitor and interpret regulatory changes, including proposed and final rules issued by global regulatory authorities, and assess their impact on company operations. Develop and maintain procedures, standard operating procedures (SOPs), and technical documentation to support regulatory compliance and operations. Collaborate with global registration teams to support product registrations across a diverse portfolio, ensuring alignment with country‑specific requirements. Implement and coordinate regulatory strategies and plans as directed by senior leadership, ensuring timely and compliant product registrations. Prepare, submit, and maintain regulatory submissions, product registrations, certifications, and facility registrations for global markets. Liaise with distributors, in‑country consultants, inter‑company partners, and commercial teams to fulfill regulatory requirements for product registration and compliance. Review and evaluate product, manufacturing, and labeling changes to determine regulatory reporting obligations and ensure continued compliance. Serve as a strategic regulatory partner, providing guidance on complex compliance landscapes and facilitating global product approvals. Uphold and integrate Envista CIRCLe values into daily work, fostering customer‑centric and ethical relationships with internal and external stakeholders. Stay informed of new regulatory developments by reviewing relevant publications and industry updates. Perform special projects and assignments as directed by Manager. Qualifications Bachelor’s Degree and 2+ years of Regulatory Affairs experience in medical devices or a regulated industry. Master’s Degree with 1+ year of Regulatory Affairs experience in medical devices or a regulated industry (preferred). Strong working knowledge of the European Medical Device Regulation (EU MDR), including demonstrated experience with CER, SSCP, PMS, and PSUR. Preferred Qualifications Advanced degree or RAC certification. Master’s in Regulatory Science. International submissions experience (e.g., APAC, LATAM, Australia TGA, Health Canada, EU). Skills & Abilities Respectful, open‑minded, and willing to take an educated risk. Ability to challenge the status quo and seek opportunities to set new standards. Accountable for work outcomes and proactive in identifying solutions. Strong prioritization, time‑management, and multi‑project coordination skills. Flexibility, adaptability, and effective communication with cross‑functional teams. Proficient in Microsoft Office, databases, and electronic document management systems. Enthusiastic self‑starter with excellent verbal, written, and interpersonal skills. Strong problem‑solving, critical thinking, and strategic planning abilities. Ability to interpret regulations from various countries and provide guidance. Physical Demands The employee is frequently required to sit, occasionally required to stand and walk, and may need to lift or move up to 10 pounds. Reasonable accommodations may be made for individuals with disabilities to perform the essential functions. Salary Target Market Salary Range: $85,800 - $104,800, with additional compensation including annual performance bonus, medical/dental/vision benefits, 401K match, and other applicable plans. EEO Statement Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: #J-18808-Ljbffr