Senior Regulatory Affairs Specialist

Company: Fortive
Location: Irvine
Posted on: April 5, 2021

Job Description:

COVID-19 update: To keep all of us safe and healthy, we're--making changes to our job postings and hiring process. Learn more Operating Company: Advanced Sterilization Products category: Corporate location: Irvine, California, United States Posting Date: Mar 1st 2021 Job Schedule (FT/PT): Full-time Job Level: Individual Contributor Requisition Number: ADV001404 To provide administrative and technical support to regulatory affairs management in order to facilitate compliance
with all FDA and other U.S. and international regulatory requirements. This position provides direct Worldwide
Regulatory support to lifecycle management (LCM) and new product development (NPD) cross-functional project
teams, including in-depth team involvement for complex projects; evaluation of proposed product modifications
for global Regulatory impact; and documentation of required change impact assessments and Regulatory Strategies Under minimal supervision, coordinates, compiles, and submits Regulatory documents to FDA and other Regulatory Agencies, including EPA and International Authorities. Also includes the preparation of international documents, including Technical Files. Works with Management to ensure rapid and timely approval of new products and continued Regulatory support of marketed products. With minimal supervision, provides Regulatory support to project teams. With minimal supervision, creates detailed Regulatory Plans. Includes in-depth team involvement, including Core Team membership for complex projects.

• Evaluates proposed product modifications for Regulatory impact on a world-wide basis. Completes
• Regulatory Assessments as needed.
• Ensures compliance with FDA and other applicable regulations and interpretations.
• Prepares responses to FDA questions and other Regulatory correspondence.
• Works under minimal supervision, with benefit of previous regulatory experience.
• Requires a general use and application of Regulatory concepts, practices and techniques.
• Develops solutions to a variety of problems of moderate scope and complexity.
• Errors in judgment or failure to achieve results would normally require a moderate expenditure of resources
• to rectify.
• Participates in the development, review and approval of product labeling.
• Review and approval of promotional materials.
• Responsible for communicating business related issues or opportunities to next management level Minimum Qualifications:
  • Bachelor's Degree
  • Minimum of 4 years related work experience
  • Minimum of 2 years of experience with MS, or equivalent knowledge and skills, necessary to
  • satisfactorily perform the position's responsibilities.
  • Related Regulatory and/or Quality Assurance experience. Preferred Qualifications and Knowledge:
    • Proper application of Title 21 of the US Code of Federal Regulations
    • Proper application of Part 800-1299 (21 CFR 800-1299)
    • Proper application of US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k)
    • Proper application of European Medical Devices Directive (93/42/EEC as amended by 2007/47/EC)
    • Proper application of Quality Management System Standard ISO 13485
    • Proper application of Risk Management Standard ISO 14971
    • Excellent written and oral communication skills.
    • Good and analytical thinking, problem solving and investigative skills.
    • Proficiency in Microsoft Office and all related applications. Fortive is a global family of more than 20 industry-leading industrial growth and technology companies, united by a shared purpose: to make the world stronger, safer, and more effective by providing essential technology for the people who accelerate progress. Here, you get the excitement of a "startup" with the stability and predictability of an organization strongly grounded in its roots and with a proven track record of growth. There's no limit to what you can learn, or the impact you can make: for you, for us, for growth. Come join our team at Advanced Sterilization Products (ASP) and be part of a global leader in infection prevention solutions for the healthcare industry. With advanced products, technologies, and workflows for medical sterilization and disinfection, ASP is dedicated to defending the lives of patients, families, healthcare workers, providers, and communities. Add your talent to our extraordinary team and help us in our mission to make healthcare safer for everyone. ASP is based in Irvine, California with core sites in Everett, Washington and Schaffhausen, Switzerland plus many more offices around the world.-- "The company in which you have expressed employment interest is a subsidiary or affiliate of Fortive Corporation. The subsidiary or affiliate is referred to as a Fortive Company. Fortive Corporation and all Fortive Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, ancestry, sex (including pregnancy, childbirth and related medical conditions), age, marital status, disability, veteran status, citizenship status, sexual orientation, gender identity or expression, and other characteristics protected by law. The "EEO is the Law" poster is available at: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. Individuals who need a reasonable accommodation because of a disability for any part of the employment process should call 1-866-272-5573 or e-mail applyassistance@fortive.com to request accommodation." Get tailored job recommendations based on your interests. Category: Sales, Marketing & Service Location: Irvine, California, United States Job Type: Full-time Category: Sales, Marketing & Service Location: Washington, District of Columbia, United States Job Type: Full-time Category: Corporate Location: Maryland, United States, North America Job Type: Full-time Category: Corporate Location: Miami, Florida, United States Job Type: Full-time For you. For us.
      For growth.
      We have the soul of a start-up, but the benefits and learning opportunities of a larger company. That means you can aspire high, matter more, and distinguish yourself through your contributions.--We are a place where people who share a drive and passion to make a personal difference can learn, grow, and achieve. Join Our Talent Community We will notify you about relevant positions, and keep you in mind whenever we have interesting opportunities. Come get them. Fortive Corporation and all Fortive Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Individuals who need a reasonable accommodation because of a disability for any part of the employment process should call 1-866-272-5573 or e-mail applyassistance@fortive.com to request accommodation.

Keywords: Fortive, Irvine , Senior Regulatory Affairs Specialist, Other , Irvine, California