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 knowledge as a Regulatory leader to make a global impact? The Sr. Manager, Regulatory Affairs will lead a team of RA professionals focused on supporting ASP's Terminal Sterilization product line. This role will develop and implement regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations and standards. The position is also responsible for providing guidance to project teams and company leadership.

Duties and Responsibilities

- Provides regulatory guidance and direction, inclusive of potential risks, to business partners and collaborators.

- Develops and proposes regulatory strategies in cooperation with cross-functional partners.

- Manages and oversees the generation of documentation for submission to regulatory agencies to secure global product clearances and approvals.

- Interacts with regulatory agencies as needed, including pre- and post-submission discussions and negotiations, to ensure timely product approval.

- Works collaboratively with regulatory and cross-functional business partners, along with other external partners to achieve and maintain compliance with regulatory requirements.

- Creatively identifies risk-based solutions and strategies to solve complex operational and organizational problems.

- Reviews and approves advertising and promotional materials as defined by standard procedures to ensure compliance with any applicable regulations, standards, policies, and procedures.

- Guides team in the coordination and submission of regulatory documentation to FDA, Notified Bodies, and other regulatory agencies.

- May manage multiple related teams, ensuring allocation of resources to align with established priorities, business objectives, and annual plan.

- Ensures that all proposed product modifications are evaluated for global regulatory impact.

- Assesses regulation and standard changes for regulatory impact.

- Participates in and supports internal and third-party audits.

- Provides support and input to ensure achievement of Quality System compliance objectives.

- Supervises the day-to-day activities of direct reports and contractors, as required.

- Creates an inclusive team-oriented environment and empowers employees through feedback, coaching, mentoring, and career development support.

- Carries out supervisory responsibilities in accordance with organizational policies and applicable laws. These responsibilities include interviewing, candidate selection, hiring, and training employees; conducting performance evaluations and development conversations; rewarding and disciplining personnel and proactively resolving issues, as required.

- Actively uses appropriate elements of the Fortive Business System (FBS) and fosters Fortive 9 behaviors.

- Communicates business-related issues or opportunities to management.

- 10% - 20% domestic and international travel may be required.

Education and Years of Experience

- Bachelor's degree required; Advanced degree preferred
- Minimum of 8 years of medical device industry experience
- Minimum of 2 years of people leadership/supervisory experience

Knowledge, Skills, and Abilities

- Ability to make sound decisions under pressure with reasonable foresight as to outcomes

- Strong collaboration skills and big picture understanding with attention to detail

- Knowledge of FDA regulatory compliance requirements for medical devices

- Knowledge of EU MDD/MDR requirements

- Ability to balance multiple contending priorities effectively

- Strong interpersonal, organizational, negotiation, and problem-solving skills

- Ability to make and carry out difficult and often unpopular decisions

- Prior 510(k) authoring and submission experience

- Prior third-party audit participation and support

- International medical device Regulatory Affairs experience

- Advertising, promotion, and labeling approval experience

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.