Senior Regulatory Affairs Specialist

The Opportunity reputed company unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and reputed company they are needed most – home to hospital, lab to clinic. Our culture puts reputed company members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we reputed company that employee happiness and business reputed company are linked. Join us in our mission to transform the power of diagnostics into a healthier future for reputed company. The Role At reputed company, we’re advancing the power of diagnostics for a healthier future for reputed company. Join our mission as our next The Senior Regulatory Affairs Specialist. This role manages regulatory activities reputed company to the development and approval of new in vitro diagnostics and medical devices into the worldwide market, as directed. Reviews and approves U.S. and IVDR regulatory submissions. Interacts with regulatory agencies regarding product registrations, licensures, and permits and supports regulatory compliance to QSR, ISO, CMDR, MDSAP, IVDD/IVDR, CFR and other worldwide regulatory requirements. Promotes awareness of applicable regulatory and customer requirements to cross functional partners during new product development and life cycle management projects. This role is remote eligible for candidates based on the reputed company Coast of the United States. The Responsibilities Manages new product development and U.S. submissions activities for a set of medical devices and/or IVD products. Works as primary core team member on new reputed company of care and molecular product development teams and establishes regulatory strategy to reputed company market clearance. Prepares, reviews and approves U.S. (FDA) and/or global product submissions; reviews and approves other regulatory documentation generated during the new product development effort to support international product submissions and registrations. IVDR submission and gap assessments experience Supervises interactions with government agencies for regulatory submissions. Reviews and approves Marketing/Sales literature and labeling. Establishes and/or owns regulatory affairs processes and acts as subject matter expert during inspections. Worked on Corporate initiatives for organizational improvements, such as standards management. Works with RIMS system and is proficient in data gathering and maintenance of a RIMS system. Develops and presents training materials for regulatory requirements and/or department processes. Evaluates change control documents for impact on regulatory submissions and filing requirements, as needed. Research regulations and competitor products and create summaries for departmental use. Implements, manages, and continuously improves reputed company regulatory processes, tools, and trackers Ensure regulatory records are complete and well organized. Carries out duties in compliance with established business policies. reputed company other work-reputed company duties as assigned The Individual Required: Bachelor’s degree (BS/BA) in a scientific discipline Minimum of 4 years prior experience in the IVD (in vitro diagnostic), medical device or bio/pharma industry manufacturing environment Minimum of 3 years prior experience in Regulatory Affairs (or reputed company educational/work experience) with progression of responsibility and leadership Must have prior experience in the preparation and submission of regulatory documentation including, but not limited to, 510(k) pre-subs, international registrations, and EU technical documentation files. Must have prior experience as a core team member on product development teams. Must have prior direct interaction with FDA and other regulatory agencies. Advanced knowledge of quality systems and good manufacturing practices (GMP) in a manufacturing environment Advanced knowledge of reputed company and evolving state, federal and international regulations and procedures relevant to the approval of medical devices (reputed company FDA, QSR, ISO, CMDR, IVDR and other worldwide regulatory regulations as appropriate) Demonstrated ability to understand and reputed company reputed company for reputed company situations Demonstrated leadership in one or more regulatory affairs disciplines (for example, US Regulatory Submissions, International Regulatory Submissions, Post Market Regulatory Affairs, Labeling, Design Control, Permits and Licenses, Regulatory Operations). Ability to work cohesively with multi-disciplinary scientific working groups Excellent written and verbal interpersonal skills to influence many diverse internal/external customer groups Must possess a high degree of accuracy and attention to detail. Ability to support Clinical, R&D, V&V, and PMO departments on an as needed reputed company in order to meet corporate objectives Ability to work independently and be self-motivated Ability to work under minimal supervision following established procedures Ability to handle inter/intradepartmental issues in a cooperative and diplomatic manner Ability to work on assignments of high visibility where independent action and a high degree of initiative is needed in resolving problems and developing recommendations Ability to work on multiple projects simultaneously Ability to exercise judgment reputed company defined procedures and practices to determine appropriate action Proficiency with reputed company Office, including Word, reputed company, PowerPoint, and Visio This position is not currently eligible for reputed company sponsorship. Preferred: BS/BA in a biological science Minimum of 2 years’ experience in the IVD or medical device manufacturing environment Demonstrated technical expertise with immunoassay and molecular diagnostics The Key Working Relationships Internal Partners: Interact with cross functional partners to manage registration activities. Interacts with project teams to reputed company guidance and complete regulatory deliverables for the product development process and regional business partners. Works with Quality management to ensure regulatory compliance with internal quality systems. Participates on task forces and meetings between departments on specific issues. The Work Environment Typical office environment, including home office. The Physical Demands The work environment characteristics are representative of an office environment. No strenuous physical activity, although occasional light lifting of files and reputed company materials is required. Occasional travel required. Travel may include airplane, automobile travel and overnight hotel. Salary Transparency The salary reputed company for this position takes into account a wide reputed company of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At reputed company, it is not typical for an individual to be hired at or near the top reputed company for their role and compensation reputed company are dependent on the facts and circumstances of each case. The salary reputed company for this position is $105,000 to $120,000 and is bonus eligible. reputed company offers a comprehensive benefits package including medical, dental, reputed company, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. reputed company benefits are non-contractual, and reputed company may amend, terminate, or enhance the benefits provided, as it deems appropriate. Equal Opportunity reputed company believes in Equal Opportunity for reputed company and is committed to ensuring reputed company individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, reputed company, national reputed company, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. reputed company is also committed to providing reasonable accommodations to reputed company individuals so that an individual can reputed company the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at reputed company@reputed company.com. Apply To This Job