Regulatory Affairs Specialist jobs in Miami, FL

Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)

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Staff Regulatory Affairs
  • Beckman Coulter Diagnostics
  • Miami, FL FULL_TIME
  • 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 Staff Regulatory Affairs position for Beckman Diagnostics is a high-level strategist, individual contributor and subject-matter-expert responsible for creating and executing regulatory strategies for new product development pre-market activities and managing complex issues that may have significant impact on the business.

    This position is in the Hematology and Urinalysis business unit based in Miami, part of the Regulatory Affairs team, reporting to the Director of Regulatory Affairs. The role will be hybrid in Miami, FL (Relocation eligible) or may work fully remote (CST/EST time zones).

    At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a fully remote or hybrid work arrangement in which you can work part of the time at the Company location identified above and part of the time remotely from your home. Additional information about these arrangements will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide.

    This individual is accountable for leading global regulatory initiatives, working with third parties as appropriate. They will build consensus while championing global regulatory initiatives for projects and drive pre-market regulatory initiatives to ensure the development and implementation of sophisticated and aggressive regulatory strategies to give Beckman Coulter a driven competitive edge.

    If you thrive in a fast-paced role and want to contribute to a world-class Regulatory Affairs organization—read on!

    In this role, you will have the opportunity to:

    • Establish the need for and prepare regulatory submissions (e.g., 510k and USFDA Pre-submission), negotiate the resolution of agency questions, and secure market clearance and/or approval for new products and/or changes to existing products.
    • Collaborate with Program Managers, technical staff, and cross-functional project teams to provide regulatory strategy for devices and resolve action items and deliverables needed for market clearance.
    • Create and manage Technical Files in compliance with IVDR and work with international colleagues on establishing design dossiers for their intended market for new product development and design changes.
    • Support the manufacturing lines when nonconformance exists to ensure appropriate regulatory assessments and requirements and provide regulatory oversight in support of design changes.
    • Assure sound post-market product regulatory strategies including minimizing the risk of negative post-market submissions needed for design changes, such as agency review delays.

    The essential requirements of the job include:

    • Bachelor's Degree with 9 years of experience in life sciences, or a Master’s degree with 7 Years of experience in life sciences, or Doctorate with 4 years of experience in life sciences
    • Subject matter expertise in registration and commercialization of medical devices (e.g., 510(k) to the FDA) and experience communicating with regulatory agencies including FDA, Health Canada, and EU regulatory authorities.
    • Experience with medical device development process, design changes, and design controls; establishing and implementing premarket regulatory strategy; writing and submitting premarket submissions to regulatory agencies; preparing submissions for FDA establishment registrations, Canadian site license renewals, US State licenses and USDA licenses.
    • Works well independently and is pragmatic with strong problem-solving skills.

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

    • Knowledge of EU IVDR regulations.
    • RAC certificate
    • International experience with products in China or Europe

    At Danaher, we work to create and sustain an inclusive culture in which diversity within our workforce creates a competitive advantage in the markets we serve. By building and maintaining a culture rooted in inclusive values, we maximize the unique perspectives and fresh ideas available to drive our innovation, fuel our growth, and ensure our technologies and products serve a global customer base. A diverse and inclusive workforce strengthens Danaher and ensures the best team continues to win. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.

    We are on a journey as an organization to increase the diversity of our associate population globally and to foster an environment where each person feels that they belong at Danaher.

    At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

  • 20 Days Ago

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Manager, Regulatory Affairs
  • Catalyst Pharmaceuticals
  • Coral, FL FULL_TIME
  • The Regulatory Manager will provide hands-on support to the day-to-day Regulatory functions, including preparation, formatting, and editing of clinical components of documents for health authority sub...
  • 16 Days Ago

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Staff Regulatory Affairs
  • Beckman Coulter
  • Miami, FL FULL_TIME
  • 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...
  • 1 Month Ago

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Staff Regulatory Affairs
  • Danaher
  • Miami, FL FULL_TIME
  • 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 ...
  • 1 Month Ago

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Director of Regulatory and Legislative Affairs (Remote)
  • Spearmint Energy
  • Florida, NY FULL_TIME
  • The Company:Spearmint Energy aims to be the preeminent green merchant trading company developing, owning, operating, and trading around energy storage, solar, and wind resources to reduce grid volatil...
  • 19 Days Ago

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Regulatory Affairs & Contract Management Manager
  • Adistec
  • Miami, FL FULL_TIME
  • Job Summary: Regulatory Affairs & Contract Management Manager will oversee the Compliance & Contracts while running and enhancing a companywide compliance program ensuring compliance of Business Pract...
  • 19 Days Ago

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0 Regulatory Affairs Specialist jobs found in Miami, FL area

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Senior Regulatory Affairs Specialist
  • Medtronic, plc
  • Hialeah, FL
  • Responsible for coordinating the planning, preparation, assembly, and review of regulatory submissions to the FDA, Notif...
  • 3/28/2024 12:00:00 AM

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Product Developer
  • The Judge Group
  • Miami, FL
  • As the Product Developer, you are accountable for the development for products sold by the business and supporting rapid...
  • 3/28/2024 12:00:00 AM

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Category Manager Specialty Meats, Sausages & Produce
  • The Judge Group
  • Miami, FL
  • As the Category Manager, you are accountable for the development for products sold by the business and supporting rapid ...
  • 3/28/2024 12:00:00 AM

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Finance - Global Fund Finance - Blackstone Credit AVP
  • Blackstone
  • Miami, FL
  • Blackstone is the world's largest alternative asset manager. We seek to create positive economic impact and long-term va...
  • 3/28/2024 12:00:00 AM

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Staff Regulatory Affairs Specialist, Software (Remote)
  • Stryker Corporation
  • Fort Lauderdale, FL
  • Why RA/QA at Stryker? Are you interested in working for a global company where you can work across functions and on a wi...
  • 3/27/2024 12:00:00 AM

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Regulatory Compliance Officer
  • EFG International
  • Miami, FL
  • Job Description Tasks and Responsibilities Conduct regular compliance testing on portfolio for compliance with SEC regul...
  • 3/26/2024 12:00:00 AM

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Complex Director of Finance
  • The Sagamore Hotel
  • Miami Beach, FL
  • Compensation Type: Yearly Highgate Hotels: Highgate is a premier real estate investment and hospitality management compa...
  • 3/25/2024 12:00:00 AM

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Director of Finance
  • Betsy Hospitality Management, LLC
  • Miami Beach, FL
  • Job Description Job Description The Betsy, located on South Beach’s iconic Ocean Drive, is considered one of the country...
  • 3/24/2024 12:00:00 AM

Miami, officially the City of Miami, is the cultural, economic and financial center of South Florida. Miami is the seat of Miami-Dade County, the most populous county in Florida. The city covers an area of about 56.6 square miles (147 km2), between the Everglades to the west and Biscayne Bay on the east; with a 2017 estimated population of 463,347, Miami is the sixth most densely populated major city in the United States. The Miami metropolitan area is home to 6.1 million people and the seventh-largest metropolitan area in the nation. Miami's metro area is the second-most populous metropolis i...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$73,467 to $98,456
Miami, Florida area prices
were up 2.9% from a year ago

Regulatory Affairs Specialist in Long Beach, CA
In addition to keeping informed of licensing and legal documentation requirements, a regulatory affairs specialist is involved in less-visible yet vastly important industry issues, such as packaging and labeling.
December 16, 2019
Regulatory Affairs Specialist in Albuquerque, NM
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
February 20, 2020
Regulatory Affairs Specialist in Petaluma, CA
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
The regulatory affairs industry plays an important role in ensuring the safety of countless products that Americans use every day—from food and beverages to pharmaceuticals and medical devices to electronics and more.
February 02, 2020