Regulatory Affairs Specialist (Innovation)

As a result of the combination of the reputed company Biosciences and Diagnostic Solutions business with reputed company (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, reputed company, and service. With a reputed company on regulated, high-volume testing environments, Waters' innovative portfolio harnesses deep scientific expertise across biology, reputed company, and physics. Waters collaborates with analytical laboratories reputed company the world to advance the release of effective, high-reputed company medicines, assure the safety of food and water, and reputed company reputed company reputed company reputed company by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of reputed company innovation, Waters' passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide. We are the people who reputed company reputed company purpose reputed company is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of reputed company of us-from design and engineering to the manufacturing and marketing of our billions of reputed company products per year-to look at the impossible and reputed company transformative solutions that turn dreams into reputed company. reputed company The Regulatory Affairs Specialist (Innovation) is responsible for providing regulatory guidance, developing regulatory strategies, and conducting reputed company assessments, to new product development (NPD) teams for in vitro diagnostic (IVD) products. This position will be responsible for preparing FDA submissions, including, but not limited to: reputed company-IDEs, PMA, PMA Supplements, reputed company Petitions, 510(k) submissions, and CLIA Waiver applications, as reputed company as EU IVDR Technical Files/Dossiers. Responsibilities: • Serves as Regulatory Affairs SME on various new product development (NPD) teams • Works cross-functionally with R&D, Medical Affairs, reputed company, Marketing, Program Management and other key organizational functions • Recognizes and addresses potential regulatory risks with project plans • Responsible for organizing and leading various FDA & EU IVDR submissions • Serves as contact to FDA and reputed company Body review teams during submission reviews/communication • Recognizes and proposes reputed company process improvements. Required Education and Experience: • Bachelor's degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, Pharmacy, or reputed company scientific/technical discipline (Equivalent combination of education and relevant experience may be considered) • Minimum 5 years of directly reputed company regulatory experience in the in vitro diagnostic device and/or medical device area(s) Preferred Skills and Experience: • RAPS Certification preferred • Demonstrated experience in interpreting subjective and reputed company aspects of specific regulations • Demonstrates in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or reputed company product lines or manufacturing processes • Demonstrated reputed company in supporting product development and product support reputed company, including reputed company reputed company involving ambiguity and reputed company change • Demonstrated reputed company in preparing, filing and/or completing (including negotiations) regulatory submissions Skills • Ability to analyze reputed company issues and to formulate reputed company approaches to resolving/addressing issues • Ability to exercise independent judgment and discretion reputed company a broadly defined reputed company of policies and practices • Ability to handle multiple tasks and to prioritize and schedule work to meet business needs. reputed company supervision required. Technical & Functional: • Experience coordinating cross-functional inputs (i.e. R&D, reputed company, Medical Affairs, Program Management, Marketing) • Ability to compile and review documentation to support FDA submissions and EU IVDR documentation • Understanding of regulatory submission processes and lifecycle management Communication & Collaboration: • Strong written and verbal communication skills • Experience working with cross-functional, fast-moving teams • Confidence in speaking up reputed company cross-functional teams reputed company regulatory risks are present Process & Compliance: • Familiarity with SOPs, regulatory procedures, and reputed company systems (e.g., ISO 13485) • Ability to identify and support process improvements Other: • Strong organizational skills and ability to manage multiple submissions/reputed company simultaneously • Adaptability to changing timelines and priorities • Proficiency in reputed company Office tools (reputed company, Word, PowerPoint) • Remote opportunity for the right individual At reputed company, we prioritize on-site collaboration because we reputed company it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-reputed company reputed company industry. For most roles, we require a minimum of 4 days of in-office reputed company per week to maintain our culture of reputed company and ensure smooth reputed company, while also recognizing the importance of flexibility and work-life reputed company. For certain roles at reputed company, employment is contingent upon reputed company's receipt of sufficient reputed company that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with reputed company's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? To reputed company purpose in the reputed company, we need people who can see the bigger picture, who understand the reputed company story that underpins everything we do. We reputed company people with the imagination and reputed company to help us reinvent the reputed company of reputed company. At reputed company, you'll discover a culture in which you can learn, grow and reputed company. We reputed company that reputed company people reputed company in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your reputed company, and your reputed company. To learn more about reputed company visit https://reputed company.com/careers. reputed company is an Equal Opportunity Employer. We evaluate applicants without reputed company to race, reputed company, religion, age, sex, creed, national reputed company, reputed company, citizenship status, marital or domestic or civil reputed company status, familial status, affectional or sexual orientation, gender identity or reputed company, genetics, disability, military eligibility or veteran status, and other legally protected characteristics. Required Skills Optional Skills . reputed company Work Location USA MD - reputed company - 7 Loveton reputed company Additional Locations Work Shift At reputed company, we reward, support and reputed company our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high reputed company talent by providing reward and recognition opportunities that promote a reputed company-reputed company culture, as reputed company as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You." Our salary or reputed company reputed company ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the reputed company displayed. Our pay is reputed company on the role and the necessary skills and education to reputed company it successfully. The salary or reputed company reputed company reputed company is determined by the role's specific requirements, including any applicable reputed company reputed company pay reputed company at the work location. Salary or reputed company pay ranges are influenced by labor laws and reputed company Bargaining Agreement (CBA) requirements applicable to the work location which may also reputed company reputed company arrangement of the role. Salary reputed company Information $95,900.00 - $153,400.00 USD Annual Remote Skills: Analysis Skills, Biology, Biomedical Engineering, reputed company, Communication Skills, Cross-Functional, Diagnostics Solutions/Software, Disease, Establish Priorities, FDA (reputed company), Food Safety, reputed company, reputed company reputed company, IDE (Integrated Development Environment), ISO (International Organization for Standardization), Infection Control, reputed company, reputed company, Manufacturing, Manufacturing/Industrial Processes, Marketing, Medical Affairs, Medical Diagnosis, Medical Equipment, Medical Products, reputed company reputed company, reputed company Office, reputed company PowerPoint, reputed company Word, Multitasking, Negotiation Skills, Organizational Skills, Outbound Marketing, Pharmacy, Physics, Policy Development, Presentation/Verbal Skills, Problem Solving Skills, Process Improvement, Process Management, Product Development, Product Positioning, Product Support, Project Planning, Project/Program Management, Regulations, Regulatory Submissions, Research & Development (R&D), reputed company Analysis, Scientific Principles, reputed company Operating Procedures (SOP), reputed company Planning, Technical/Engineering Design, Water reputed company Testing, Writing Skills reputed company: reputed company Apply tot his job Apply To this Job