Senior Regulatory Affairs Program Lead

Advanced Sterilization Products, Inc.; Irvine (CA); Remote; USD 101,000 - 189,000; Full time

Job summary

A leading global provider of innovative sterilization and disinfection solutions is seeking a Sr. Regulatory Affairs Program Lead. This position involves ensuring compliance with regulatory requirements, supporting new product development, and providing solutions to complex regulatory challenges. Candidates should possess strong analytical and communication skills, along with extensive experience in regulatory affairs, particularly with FDA regulations.

Benefits

Bonus as part of total compensation package

Qualifications

• Experience with FDA and international regulatory requirements.
• Knowledge of ISO standards and risk management.
• Understanding of the US Federal Food, Drug, and Cosmetic Act.

Responsibilities

• Ensures compliance with regulatory agency regulations.
• Writes, coordinates, and submits Regulatory documents to FDA.
• Provides regulatory guidance to cross-functional project teams.

Skills

Analytical thinking

Problem solving

Excellent written and oral communication

Education

6-8 years of related work experience

Minimum of 4 years of experience with MS

Proper application of Title 21 of the US Code of Federal Regulations

Proper application of Quality Management System Standard ISO 13485

Job description

The Sr. Regulatory Affairs Program Lead (Sr. RA Program Lead) provides administrative and technical support to regulatory affairs management in order to facilitate compliance with all FDA and other U.S. and international regulatory requirements throughout the product life cycle. The 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. The role assists in the identification and development of operational improvements of Regulatory Affairs processes.

Responsibilities:

• Ensures compliance with regulatory agency regulations and interpretations.
• Writes, 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 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.
• Provides solutions to problems with moderate complexity and risk. Works independently, with guidance in only the most complex situations.
• 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 standards.
• Ensures preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
• Prepares responses to Regulatory authority questions, as well as other Regulatory correspondence.
• May communicate and negotiate with regulatory authorities.
• Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
• Requires use and application of Regulatory concepts, practices and techniques.
• 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 approval of advertising and promotional materials.
• Communicates business related issues or opportunities to next management level.
• Uses appropriate elements of the Fortive Business System (FBS) and exemplifies the Fortive 9 behaviors.
• Responsible for communicating business related issues or opportunities to next management level.
• Performs other duties assigned as needed.

Qualifications:

• 6- 8 years of related work experience
• Minimum of 4 years of experience with MS, or equivalent knowledge and skills, necessary to satisfactorily perform the position’s responsibilities.
• 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) and
• European Medical Device Regulation (2017/745)
• Proper application of Quality Management System Standard ISO 13485
• Proper application of Risk Management Standard ISO 14971
• 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.

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Fortive Corporation Overview

Fortive’s essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product design, and healthcare safety solutions.

We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in software-powered workflow solutions, data-driven intelligence, AI-powered automation, and other disruptive technologies. We’re a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to groundbreaking sustainability solutions.

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

At Fortive, we believe in you. We believe in your potential—your ability to learn, grow, and make a difference.

At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone.

At Fortive, we believe in growth. We’re honest about what’s working and what isn’t, and we never stop improving and innovating.

Fortive: For you, for us, for growth.

About Advanced Sterilization Products

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 in the fight to protect patients against hospital acquired infections, which are a leading cause of morbidity and mortality. ASP’s products, which are sold globally, include the STERRAD system for sterilizing instruments and the EVOTECH and ENDOCLENS systems for endoscope reprocessing and cleaning.

We Are an Equal Opportunity Employer. Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all 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. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment application process, please contact us at [e-mail].

Bonus or Equity
This position is also eligible for bonus as part of the total compensation package.

Pay Range
The salary range for this position (in local currency) is 101,500.00 - 188,500.00