ASP is a leading global provider of innovative sterilization and disinfection solutions, and a
pioneer of low-temperature hydrogen peroxide sterilization technology.

ASP’s mission is to protect patients during their most critical moments. We support healthcare
facilities protecting patients against hospital-acquired infections, which are a leading cause of
morbidity and mortality.

We are always leaning into the next challenge, imagining the next breakthrough, and crafting
the next innovation. At ASP, we believe in you. We believe in your potential – your ability to
learn, grow, and contribute in meaningful ways.

We believe in the power of phenomenal people working together to innovate and solve
problems no one could tackle alone.

We are Advanced Sterilization Products.

Your Impact

Want to use your regulatory knowledge to make a global impact? The Senior Regulatory Affairs
Program Lead is your opportunity to do just that! Provide direct Worldwide Regulatory support to
lifecycle management (LCM) and new product development (NPD) project teams. This involves
cross-functional collaboration on complex projects and programs; evaluation of proposed
product modifications for global Regulatory impact; and documentation of required change
impact assessments and Regulatory Strategies. As Program Lead, this position supports
regulatory affairs management to facilitate compliance with all FDA and other U.S. and
international regulatory requirements throughout the product life cycle. This role also assists in
the identification and development of operational improvements of Regulatory Affairs processes.

Duties and Responsibilities

- Ensures compliance with regulatory agency regulations and interpretations. Including
FDA, and other applicable regulations and standards.

- Write, coordinate, compile, and submit Regulatory documents to FDA along with other
Regulatory Agencies, including EPA and International Authorities. Also includes the
preparation of international documents, including Technical Files and Technical
Documentation. Works with Management to ensure rapid and timely approval of new
products and continued Regulatory support of marketed products.

- May lead functional teams or projects with moderate resource requirements, risk, and/or
complexity.

- May mentor junior Regulatory Team members and delegate tasks within a well-defined
scope.

- Provides solutions to problems with moderate complexity and risk. Works independently,
with guidance in only the most complex situations.

- Creates detailed Regulatory Plans. This includes collaborative and in-depth team
involvement for multi-faceted projects.

- Evaluates proposed product modifications for Regulatory impact on a world-wide basis.
Complete Regulatory Assessments as needed.

- Ensures preparation of critical outlines, summaries, status reports, memos, graphs,
charts, tables, and slides.

- Prepares responses to Regulatory authority questions, as well as other Regulatory
correspondence.

- Gathers and assembles information vital for submissions in accordance with regulations
and relevant guidelines.

- Provides regulatory guidance to cross-functional project teams.

- Participates in the development, review, and approval of product labeling.

- Provides support to inspections/audits by FDA, the notified body, or other international
regulatory bodies by producing requested documents or answering any inquiries for
information.

- Review and approve advertising and promotional materials.

- Uses appropriate elements of the Fortive Business System (FBS) and exemplifies the
Fortive 9 behaviors. 

Education and Years of Experience

- Bachelor’s Degree with 6+ years of related Regulatory experience
- MS with 4+ years related Regulatory experience
- 4+ years of medical device experience preferred
- Advanced degree in a scientific field (engineering, chemistry, biological) preferred
- Prior experience in biologic or combination devices a plus

Knowledge, Skills, and Abilities

- International Medical Device requirements (China, Japan, Canada, Australia, Brazil,
Russia, etc.)

- Excellent written and oral communication skills

- Proficiency in Microsoft Office and related applications

- Good analytical thinking, problem-solving, and investigative skills.

Proper application of the following:

- Title 21 of the US Code of Federal Regulations
- Part 800-1299 (21 CFR 800-1299)
- US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k)
- European Medical Devices Directive (93/42/EEC as amended by 2007/47/EC) and
European Medical Device Regulation (2017/745)
- Quality Management System Standard ISO 13485
- Risk Management Standard ISO 14971

About Us

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.

ASP is part of the Fortive Corporation, a diverse team 17,000 strong, united by a dynamic,
inclusive culture and energized by limitless learning and growth. We use the Fortive Business
System (FBS) to accelerate our positive impact.

Fortive Corporation Overview

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.

EEO Statement

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.