Sr. Mgr., Regulatory Affairs (RA) & Clinical Affairs Job ID #: 1923 Company: Evident Posting Date: Feb 3, 2025 **Working Location:** **Remote** Are you looking for a company that cares about people’s lives and health, including yours? At EVIDENT, we help make people’s lives healthier, safer and more fulfilling, every day. **_Let’s inspire healthier lives, together._** We are seeking a detail-oriented and experienced Senior Regulatory Affairs (RA) & Clinical Affairs Manager to join our team. In this critical role, you will act as the FDA US Agent and Official Correspondent, ensuring compliance with FDA regulations and global clinical requirements for our medical device and in vitro diagnostic (IVD) product portfolio. You will manage global clinical affairs, oversee clinical trial activities, and act as the key point of contact for 510(k) submissions and pre-submission discussions with the FDA. This position requires a strong background in regulatory affairs, clinical trial management, and a comprehensive understanding of FDA and global regulatory pathways for medical devices and IVDs. **Clinical Evaluations** + Develop and maintain Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) in compliance with EU MDR/IVDR, FDA, and other global regulatory requirements. + Conduct systematic literature reviews, post-market clinical follow-ups (PMCF), and risk-benefit analyses to support product lifecycle management. + Collaborate with cross-functional teams (e.g., R&D, regulatory, quality, and marketing) to gather and analyse clinical evidence. + Ensure timely updates to clinical documentation to reflect regulatory changes, post-market data, and emerging risks. **Clinical Study Management** + Design and oversee clinical study protocols, including feasibility, validation, and performance evaluation studies, to meet regulatory and business objectives. + Design and oversee clinical study protocols, including feasibility, validation, and performance evaluation studies, to meet regulatory and business objectives. + Ensure clinical studies comply with Good Clinical Practice (GCP), ISO 14155, and other applicable standards. + Lead collaborations with clinical research organizations (CROs), laboratories, and external partners to ensure timely and cost-effective study execution. **Regulatory Support** + Provide clinical input for regulatory submissions (e.g., 510(k), PMA, CE marking) in alignment with FDA, EU IVDR, and international regulatory requirements. + Act as the clinical affairs subject matter expert during regulatory audits, inspections, and technical file reviews. + Collaborate with regulatory teams to address deficiencies or additional information requests related to clinical evidence. **Post-Market Surveillance** + Oversee the collection and analysis of post-market data, adverse event reporting, and PMCF studies to ensure continued product compliance and safety. + Prepare and review periodic safety update reports (PSURs) and summary of safety and performance (SSP) documents. **FDA US Agent Official Correspondent** The FDA US Agent is a mandatory role for foreign companies registering with the FDA. This representative acts as the primary point of contact between the FDA and the foreign entity. + Communication with the FDA: + Receive official notifications, including inspection requests, queries, and recall notices from the FDA. + Forward these communications promptly to the foreign company. + Inspection Support: + Assist the FDA in coordinating inspections of foreign facilities. + Serve as a liaison for addressing any issues raised during inspections. + Availability: + Ensure they are available during U.S. business hours to respond to FDA inquiries. + Emergency Contact: + Act as a direct contact for urgent matters, such as public health emergencies or product recalls. + Regulatory Submissions US FDA + Prepare, submit, and manage 510(k) premarket notifications for medical devices and IVD products. + Lead pre-submission (Q-Sub) meetings with the FDA to align on submission requirements and resolve potential regulatory hurdles. + Maintain compliance with FDA regulations, including updates to product listings and facility registrations. **MINIMUM QUALIFICATIONS** _(To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)_ **Education:** + Bachelor’s degree in a life science, biomedical engineering, or a related field. + Additional certification in clinical research, regulatory affairs, or project management is a plus. **Experience:** + Minimum 7–10 years of experience in regulatory affairs and clinical affairs for IVD or medical devices, with a proven track record of managing clinical evaluations and studies. + Hands-on experience in designing and managing clinical trials for regulatory submissions. + Experience with 510(k) submissions and pre-submission meetings with the FDA. + Deep understanding of EU IVDR/MDR, FDA regulations, ISO 14155, and GCP requirements. + Experience in designing and managing multi-regional clinical studies. **Skills:** + Strong analytical and problem-solving skills, with the ability to interpret complex clinical data. + Excellent project management and organizational abilities, with attention to detail and timelines. + Outstanding communication skills, both written and verbal, to interface effectively with internal and external stakeholders. + Proficiency in regulatory and clinical data management software/tools. + Adaptability and cultural sensitivity for managing global clinical initiatives + Well balanced between Hands-on & Strategic Development + Results-orientated + Dynamic personality with the skill to find the balance between regulatory needs and business goals and the communicate accordingly with internal & external Stakeholders. **Other Considerations (travel/hours availability, etc.):** + Residency: Must have a physical presence in the U.S. to fulfill FDA US Agent responsibilities. + Availability: Must be accessible during U.S. business hours to address FDA communications and emergencies promptly. + Travel: Willingness to travel domestically and internationally as needed for regulatory meetings, inspections, and clinical trial activities. **Core Evident Behaviors** + **Think Big** - Sets ambitious goals, thinks beyond the immediate and works outside of own area for insight and inspiration to excel + **Own the Outcome** - takes a high degree of personal accountability, ownerships and embraces a customer-centric approach to prioritization, planning and work + **Test. Decide. Go** -Open minded, willing to try new things, balances risk with agility in a culture of learning and rapid growth, moves at pace to get the right things done + **Kaizen Everywhere, Everyday** - Solicits feedback to enhance effectiveness, continually identifies and drives improvement and new ways of working, operating and thinking **MINIMUM QUALIFICATIONS** _(To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)_ **Education:** + Bachelor’s degree in a life science, biomedical engineering, or a related field. + Additional certification in clinical research, regulatory affairs, or project management is a plus. **Experience:** + Minimum 7–10 years of experience in regulatory affairs and clinical affairs for IVD or medical devices, with a proven track record of managing clinical evaluations and studies. + Hands-on experience in designing and managing clinical trials for regulatory submissions. + Experience with 510(k) submissions and pre-submission meetings with the FDA. + Deep understanding of EU IVDR/MDR, FDA regulations, ISO 14155, and GCP requirements. + Experience in designing and managing multi-regional clinical studies. **Skills:** + Strong analytical and problem-solving skills, with the ability to interpret complex clinical data. + Excellent project management and organizational abilities, with attention to detail and timelines. + Outstanding communication skills, both written and verbal, to interface effectively with internal and external stakeholders. + Proficiency in regulatory and clinical data management software/tools. + Adaptability and cultural sensitivity for managing global clinical initiatives + Well balanced between Hands-on & Strategic Development + Results-orientated + Dynamic personality with the skill to find the balance between regulatory needs and business goals and the communicate accordingly with internal & external Stakeholders. **Other Considerations (travel/hours availability, etc.):** + Residency: Must have a physical presence in the U.S. to fulfill FDA US Agent responsibilities. + Availability: Must be accessible during U.S. business hours to address FDA communications and emergencies promptly. + Travel: Willingness to travel domestically and internationally as needed for regulatory meetings, inspections, and clinical trial activities. **Core Evident Behaviors** + **Think Big** - Sets ambitious goals, thinks beyond the immediate and works outside of own area for insight and inspiration to excel + **Own the Outcome** - takes a high degree of personal accountability, ownerships and embraces a customer-centric approach to prioritization, planning and work + **Test. Decide. Go** -Open minded, willing to try new things, balances risk with agility in a culture of learning and rapid growth, moves at pace to get the right things done + **Kaizen Everywhere, Everyday** - Solicits feedback to enhance effectiveness, continually identifies and drives improvement and new ways of working, operating and thinking ****Many Evident positions are located at export-control-restricted work locations or require access to export-controlled information. To be considered for these positions, you must be a U.S. Persons. If hired, you must be able to provide valid proof of such status.** \#LI-Remote **_We realize work isn’t just a job to you._** It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you. EVIDENT is passionate about the solutions it creates for the life sciences, and industrial equipment industries. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world. Olympus has manufactured microscopes since the company’s founding in 1919. Today, EVIDENT is a leading manufacturer of optical and digital microscope systems for life science solutions. EVIDENT’s Life Sciences division supplies microscope systems for biological use in clinical, research, and educational applications. For more information, Click Here (http://www.olympus-ims.com) . It is the policy of EVIDENT to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law. Posting Notes: || United States (US) || Pennsylvania (US-PA) || Remote ||