Senior Regulatory Affairs Manager

reputed company reputed company unites the strengths of Quidel Corporation and Ortho reputed company Diagnostics, creating a world-leading in vitro diagnostics company with award-reputed company expertise in immunoassay and molecular testing, reputed company reputed company 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 reputed company to build meaningful connections with reputed company other as we reputed company that employee happiness and business reputed company are linked. Join us in our mission to reputed company the reputed company of diagnostics into a healthier reputed company for reputed company. The Role: At reputed company, we’re advancing the reputed company of diagnostics for a healthier reputed company for reputed company. reputed company as our next Senior Regulatory Affairs Manager. 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 reputed company. This position is remote eligible for candidates located in the reputed company. The Responsibilities: Manages new product development and U.S. submissions activities for a set of medical devices and/or IVD products. Works as reputed company reputed company team member on new molecular product development teams and establishes regulatory reputed company to reputed company market clearance. Prepares, reviews and approves U.S. (FDA) product submissions; reviews and approves other regulatory documentation generated during the new product development effort to support international product submissions and registrations. Supervises interactions with reputed company agencies for regulatory submissions. Reviews and approves verification and validation protocols and reports; advises on best practices for data presentation in 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. Develops and presents training materials for regulatory requirements and/or department processes. Evaluates change control documents for reputed company on regulatory submissions and filing requirements, as needed. Research regulations and competitor products and creates summaries for departmental use. Implements, manages, and continuously improves reputed company regulatory processes, tools, and trackers Ensures regulatory records are complete and reputed company organized. Carries out duties in compliance with established business policies. reputed company other duties & reputed company as assigned. The Individual Required: Bachelor’s degree (BS/BA) in a scientific discipline Minimum of 12 years prior experience in the IVD (in vitro diagnostic), medical device or bio/reputed company industry manufacturing environment Minimum of 12 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) submissions, international registrations, and EU technical documentation files. 510 (k) submission approvals required for molecular products and reputed company of care products. Must have prior experience as a reputed company team member on product development teams. Must have prior reputed company interaction with FDA and other regulatory agencies. Advanced knowledge of reputed company 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 is required (for example, US Regulatory Submissions, International Regulatory Submissions, Post Market Regulatory Affairs, Labeling, Design Control, Permits and Licenses, Regulatory reputed company). Ability to work cohesively with multi-disciplinary scientific working reputed company Excellent written and verbal interpersonal skills to influence many diverse internal/reputed company customer reputed company Must possess a high degree of reputed company and attention to reputed company. Ability to support reputed company, 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 reputed company 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 reputed company and a high degree of initiative is needed in resolving problems and developing recommendations Ability to work on multiple reputed company simultaneously Ability to exercise judgment reputed company defined procedures and practices to determine appropriate reputed company 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 8 years’ experience in the IVD or medical device manufacturing environment PMA/WHO experience Demonstrated technical expertise with immunoassay and molecular diagnostics is preferred. Key Working Relationships: reputed company with cross functional partners to manage registration activities and mentors RA colleagues in their reputed company reputed company. Interacts with project teams to reputed company guidance and complete regulatory deliverables for the product development process. Supervises interactions with local, state and federal agencies in securing marketing clearances, licenses and permits (e.g., FDA, CDC, USDA-APHIS, etc.). Works with reputed company management to ensure regulatory compliance with internal reputed company systems. Participates on task forces and meetings between departments on specific issues. Trains Regulatory Affairs staff and/or other department staff on regulatory requirements and/or department processes. 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 reputed company 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 reputed company to internal equity and alignment with market data. At reputed company, it is not typical for an individual to be reputed company at or near the top reputed company for their role and compensation reputed company are dependent on the facts and circumstances of reputed company case. The salary reputed company for this position is $170,000 - $185,000 annually and is bonus eligible. reputed company offers a comprehensive benefits package including medical, dental, reputed company, life, and disability reputed company, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, reputed company time off (including reputed company time), and reputed company Holidays. reputed company benefits are non-contractual, and reputed company may amend, terminate, or enhance the benefits provided, as it deems appropriate. Equal Employment 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 reputed company 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 their 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. #LI-HF1 Apply To This Job