SCOPE of RESPONSIBILITIES and DUTIES Work cross-functionally as a regulatory representative supporting the complete life cycle of medical devices in the Microtek/Ecolab Healthcare portfolio. Manage, prepare, submit, negotiate, and secure necessary product approvals (clearances/registrations) to support speed to market of new and changing products in specified geographic regions Ensure that all medical device registration files are maintained in accordance with applicable regulatory standards and internal standard operating procedures Work cross-functionally to maintain the Post-Market Surveillance (PMS) Process and Act as the regulatory representative for Post-Market Surveillance Manage timely responses to agency requests Provide guidance to cross-functional project teams regarding application of medical device regulatory and PMS requirements. Balance and maintain priorities in a fast-paced changing work environment; must multitask and reprioritize as necessary Maintain positive communication with cross-functional team members as well as external stakeholders Be effective with remote team meeting participation and communication Partner and collaborate with Global Healthcare colleagues as a Regulatory Representative on enterprise projects and special projects as assigned. Research, review and advise the organization on appropriate compliance and risk reduction strategies Minimum Qualifications: BS in engineering or science-related field (microbiology, biology, etc.) 8 years of regulatory/quality or related experience in medical device or related industry Experience working with Class I/Is/II medical devices Experience working directly with quality, legal, R&D, manufacturing, and marketing or consulting directly with clients Experience with Technical writing, such as regulatory plans/strategies and Technical Files Experience reviewing project deliverables; technical reports and / or standard operating procedures (SOPs) and providing regulatory perspective input Experience with US FDA regulations and EU MDR 2017/745 requirements, such as design controls, applying harmonized standards, and meeting general safety and performance requirements Knowledge of applicable international regulations and registration requirements Knowledge of post-market and adverse event reporting requirements Ability to excel in a fast-paced team environment Ability to learn business and regulatory processes Good written and verbal communication skills Ability to read and interpret technical and regulatory documents Preferred Qualifications: Master's Degree in regulatory affairs or science-related field (microbiology, biology, etc.) Excellent written and oral communication skills Ability to motivate others to achieve results Previous experience authoring procedures and/or training materials Experience in introducing and establishing new quality management processes Experience in Lean, Kaizen, Six Sigma or 6s methodologies Benefits Ecolab strives to provide comprehensive and market-competitive benefits to meet the needs of our associates and their families.to see our benefits. If you are viewing this posting on a site other than our Ecolab Career website, view our benefits at jobs.ecolab.com/working-here. Covid-19 Vaccine Notice Due to local mandates and customer requirements, applicants for certain customer-facing positions must be fully vaccinated (which in some situations requires a booster if eligible), unless a religious or medical accommodation is requested by the applicant and approved by Ecolab. Americans with Disabilities Act (ADA) Ecolab will provide reasonable accommodation (such as a qualified sign language interpreter or other personal assistance) with our application process upon request as required to comply with applicable laws. If you have a disability and require accommodation assistance in this application process, please visit the Recruiting Support link in the footer of each page of our career website. Our Commitment to Diversity and I clusion At Ecolab, we believe the best teams are diverse and inclusive, and we are on a journey to create a workplace where every associate can grow and achieve their best. We are committed to fair and equal treatment of associates and applicants. We recruit, hire, promote, transfer and provide opportunities for advancement on the basis of individual qualifications and job performance. In all matters affecting employment, compensation, benefits, working conditions, and opportunities for advancement, we will not discriminate against any associate or applicant for employment because of race, religion, color, creed, national origin, citizenship status, sex, sexual orientation, gender identity and expressions, genetic information, marital status, age, disability, or status as a covered veteran. In addition, we are committed to furthering the principles of Equal Employment Opportunity (EEO) through Affirmative Action (AA). Our goal is to fully utilize minority, female, disabled and covered veteran individuals at all levels of the workforce. Ecolab is a place where you can grow your career, own your future and impact what matters. We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance and the San Francisco Fair Chance Ordinance.