Senior Regulatory Affairs Program Lead

hace 2 semanas

Manizales, Colombia Advanced Sterilization Products A tiempo completo

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.

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

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
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

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