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Fortive Corporation Sr. Regulatory Affairs Specialist in Germany, United States

Please note this is a temporary 6 months contract

  • Under minimal supervision, coordinates, compiles, and submits Regulatory documents. Oversees and functions as co-ordinator of ASP's advertising and promotional review process.

  • Works cross-functionaly to coordinate the review and approval of these materials.

  • Evaluates proposed marketing collateral for compliance to the procedure and Veeva requirements.

  • Ensures compliance with FDA and other applicable regulations and interpretations.

  • Works under minimal supervision, with benefit of previous regulatory experience.

  • Requires a general use and application of Regulatory/Quality concepts, practices and techniques.

  • Develops solutions to a variety of problems of moderate scope and complexity. Actively pursues process improvement.

  • Participates in the development, review and approval of product marketing and educational material.

  • Support the promotional review and approval process through daily processing and tracking of submissions, verifying the quality of submissions for completeness and inclusion of supporting documentation, confirmation of final approval before releasing for distribution, and generating promotional material review and approval metrics.

  • Responsible for communicating business related issues or opportunities to next management level

  • Bachelor's degree

  • Minimum of 4 years related work experience

  • Minimum of 2 years of experience with MS, or equivalent knowledge and skills, necessary tosatisfactorily perform the position’s responsibilities

  • Related Regulatory and/or Quality Assurance experience

Fortive (http://www.fortive.com/) 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.

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