Regulatory Affairs Manager

Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.

At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.

Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges. 

The Regulatory Affairs Manager for Beckman Coulter Diagnostics is responsible for the development and execution of global regulatory strategy and tactical planning for assigned microbiology on market products or those products in development. Assures that defined regulatory strategies defined are effectively implemented and maintained in line with changing regulatory and business needs. This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured, or distributed to meet relevant global regulatory requirements.

This position is part of the Regulatory Affairs group located in Sacramento, California and will be onsite. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

You will be a part of the QRC team and report to the Sr. Director QRC responsible for microbiology quality, regulatory, and clinical. If you thrive in an amazing, multifunctional, leadership, fast paced, supporting role and want to work to build a world-class Regulatory Affairs organization—read on.

Responsibilities:

• Responsible for a product(s) with multiple driver indications within a Therapeutic Area and supports the Sr. Manager Clinical Affairs in the development & execution of the regulatory strategy. Assigned matters may have a moderate impact on business activities and operations.
• Serves as regulatory affairs liaison and interfaces with FDA for meetings, teleconferences and coordinates preparation and completion of FDA meeting briefing packages and responses. Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.
• Key contributor responsible for the preparation and review of regulatory submissions consistent within global regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review.
• Recommends and implements changes to difficult projects based on knowledge and expertise, accurate interpretation of US and Canada government regulations, guidance, as well as corporate policies and management-related considerations.
• Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).

In this role, you will have the opportunity to:

• Lead a team of regulatory professionals

• Make an impact in the antimicrobial susceptibility market

The essential requirements of the job include:

• Required Education: Bachelor’s degree (pharmacy, biology, chemistry, microbiology) or industry-related with 9+ years of experience or, Master’s degree with 7+ years of experience, or PHD with 5+ years of experience
• Demonstrates excellent negotiation skills, problem-solving skills and builds consensus.
• Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization.
• Able to deliver challenging messages effectively without compromising important business relationships.
• Proven skill at implementing successful global regulatory strategies regulatory strategies. Experience working in a complex matrix environment.

It would be a plus if you also possess previous experience in:

• Preferred Experience: 2-3 years in diagnostics regulatory activities
• Preferred Education: Advanced Degree a plus. Certifications a plus.
• Software experience is a plus (e.g. Experience interfacing with government regulatory agencies surrounding cybersecurity/software development).

The salary range OR the hourly range for this role is 140k to 160 k. This is the range t