Regulatory Affairs Specialist jobs in Sarasota, 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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Regulatory Affairs Specialist in an international medical device company
  • Mermaid Medical Group
  • Sarasota, FL FULL_TIME
  • As the Regulatory Affairs Specialist, you will be responsible for maintaining product registrations for our medical devices and helping to ensure regulatory compliance of Mermaid Medical devices throughout their entire product lifecycles. You will support the organization by providing regulatory advice and helping formulate and implement regulatory strategies across multiple projects while working with various departments across the organization such as Marketing, Clinical, R&D, and Quality Assurance.

    This job position is based out of the office located in Sarasota, FL allowing you to work efficiently with colleagues located both in the US and at the headquarter office located near Copenhagen, Denmark. Occasional international travel can be expected as you will be working daily with a global team.

    As the Regulatory Affairs Specialist, you will report to the Regulatory Manager, and you will be responsible for regulatory tasks as described below.

    Main responsibilities

    • Support maintenance of EU, US, Canadian, etc. registrations and listings for Class II/III medical devices
    • Support the organization with regulatory advice
    • Updating databases (EUDAMED/GUDID/etc.) and creating/maintaining required documentation
    • Contributing to the medical device intelligence review and monitoring
    • Coordination of post-market surveillance activities
    • Assist with the submission and management of recalls/FSN’s and adverse event/incident reports
    • Responsible for assisting in pre-market submissions, license applications, and product registrations for medical devices in target countries
    • Provide regulatory support in new product development projects
    • Supporting the Regulatory Manager communicating with responsible regulatory authorities (national/international) as well as with notified bodies by maintaining current knowledge of the developments and changes to applicable laws, regulations, and industry standards
    • Creating and maintaining Technical File documentation and submission documentation in compliance with the relevant regulatory requirements
    • Participate in corrective and preventive action (CAPA) activities
    • Support and participate in audits (internal/external)
    • Maintaining the regulatory processes within the Quality Management System
    • Drive improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System.
    • Implementing the UDI and labeling requirements together with our R&D and QA team
    • Works cooperatively with R&D, process development, quality, manufacturing, clinical, and marketing on complex projects to ensure success

    You will be working in different highly skilled international teams.

    Your skillset

    • Minimum 1-3 years of experience in a quality or regulatory role, preferably within the medical device industry
    • Knowledge and experience of the relevant regulations preferred, i.e., MDR, FDA, relevant laws, and guidelines, such as MEDDEV, applicable standards, etc.
    • Engineer or bachelor’s degree in science or a related field and/or medical device experience
    • Team player
    • Fluent English, written and spoken
    • Ability to perform detailed tasks with accuracy
    • Proficient in the use of Microsoft 365
    • Excellent organizational skills
    • Ability to juggle multiple projects and tasks at the same time

    The successful candidate has a great sense of responsibility, reliability with high-quality standards, and is committed to meeting deadlines.

    What Do You Get?
    We offer the following benefits package to full-time employees:

    • 10 annual paid holidays
    • 120 hours of paid time off annually
    • 100% of the employee premium for health and dental insurance, option to add family
    • Retirement plan with company match
    • Education benefits in the form of tuition assistance

    We also offer local relocation within the state of Florida.

    You will be part of an organization where we value teamwork and where we look out for each other. We are of the strong belief that no one can accomplish everything on their own, and therefore we value and utilize each other’s strengths. We care about and foster an environment where you can always find a helping hand across functions and borders.

    The Application Process
    Apply to be our new Regulatory Affairs Specialist by uploading a cover letter and your current curriculum vitae using the link on this site. We only receive applications through our recruitment systems.

    The applications will be reviewed on an ongoing basis.

    We look forward to receiving your application.


    About Mermaid Medical Group:
    Mermaid Medical Group is a privately owned company established in 2007. With our Nordic roots and headquarters in Denmark, we value cooperation, helpfulness, and openness. We develop, manufacture, and distribute medical devices to hospitals and end-users across Europe, the U.S., and Asia. We primarily work within solutions to diseases in the vascular system as well as other devices used in interventional radiology. We strive to be the preferred partner for manufacturers as well as hospitals and health care professionals so that together we can help even more patients.

    Being One of Us:
    We believe that as people, and as a company, We Are One. We have a culture of sticking together and doing what is best for each other and the company. We are proud of our life-saving products, and we trust that each and every one of our colleagues do their best to ensure happiness and quality of life, both for the patients who benefit from our products as well as for each other.

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Director, Quality Assurance and Regulatory Affairs
  • React Health Holdings, LLC
  • Sarasota, FL FULL_TIME
  • POSITION: Director, Quality Assurance and Regulatory Affairs FULL-TIME/PART-TIME: Full Time LOCATION: Hybrid React Health is a fast paced, growth oriented, manufacturer and distributor of medical equi...
  • 5 Days Ago

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Sarasota, FL FULL_TIME
  • Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurol...
  • 10 Days Ago

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Represen Consumer Affairs
  • PGT Innovations
  • Nokomis, FL FULL_TIME
  • Summary: Provides efficient and courteous response to consumer inquiries and complaints. Able to follow up manage cases from start to resolution by performing the following duties What You'll Do: Rece...
  • 20 Days Ago

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Bilingual Customer Affairs Representative
  • Paramount Staffing LLC
  • Venice, FL FULL_TIME
  • Paramount is seeking experienced Bilingual Customer Service professionals to provide top-notch support to our valued client in this Bilingual Customer Affairs Representative opportunity. If you're com...
  • 14 Days Ago

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Rep Consumer Affairs -Bi-lingual
  • PGT Innovations
  • Nokomis, FL FULL_TIME
  • Summary: Provides efficient and courteous response to consumer inquiries and complaints. Able to follow up manage cases from start to resolution by performing the following duties. Must be bi-lingual....
  • 22 Days Ago

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0 Regulatory Affairs Specialist jobs found in Sarasota, FL area

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Associate Personal Banker South Manatee
  • WELLS FARGO BANK
  • Bradenton, FL
  • Why Wells Fargo: Are you ready for the next step in your career? This is where it begins - at a company known for our "W...
  • 3/28/2024 12:00:00 AM

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Personal Banker Bradenton District
  • WELLS FARGO BANK
  • Sarasota, FL
  • Why Wells Fargo: Are you ready for the next step in your career? This is where it begins - at a company known for our "W...
  • 3/27/2024 12:00:00 AM

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Associate Personal Banker Palmer Ranch
  • WELLS FARGO BANK
  • Sarasota, FL
  • Why Wells Fargo: Are you ready for the next step in your career? This is where it begins - at a company known for our "W...
  • 3/27/2024 12:00:00 AM

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Personal Banker Bradenton District
  • WELLS FARGO BANK
  • Bradenton, FL
  • Why Wells Fargo: Are you ready for the next step in your career? This is where it begins - at a company known for our "W...
  • 3/27/2024 12:00:00 AM

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Personal Banker Bradenton District
  • WELLS FARGO BANK
  • Ellenton, FL
  • Why Wells Fargo: Are you ready for the next step in your career? This is where it begins - at a company known for our "W...
  • 3/27/2024 12:00:00 AM

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Senior Manager, Financial Reporting
  • HELIOS TECHNOLOGIES INC
  • Sarasota, FL
  • Job Details Job Location Helios Technologies Incorporated - Sarasota, FL Position Type Full Time Education Level 4 Year ...
  • 3/26/2024 12:00:00 AM

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Finance Manager
  • CAMPBELL RV, INC.
  • Sarasota, FL
  • NO RECRUITERS PLEASE (WE ARE NOT INTERESTED) **About Us:** We are a leading RV dealership located in Sarasota, Florida, ...
  • 3/25/2024 12:00:00 AM

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Finance Manager
  • Leeds Professional Resources
  • Sarasota, FL
  • Leeds Resources is working with a company in Sarasota that is looking for a Finance Manager. The Financial Manager will ...
  • 3/24/2024 12:00:00 AM

Sarasota (/ˌsærəˈsoʊtə/) is a city in Sarasota County on the southwestern coast of the U.S. state of Florida. The area is renowned for its cultural and environmental amenities, beaches, resorts, and the Sarasota School of Architecture. The city is at the southern end of the Tampa Bay Area, north of Fort Myers and Punta Gorda. Its official limits include Sarasota Bay and several barrier islands between the bay and the Gulf of Mexico. According to the U.S. Census Bureau, in 2013 Sarasota had a population of 53,326. In 1986 it became designated as a certified local government. Sarasota is a prin...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$72,293 to $96,882
Sarasota, Florida area prices
were up 1.5% 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.
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Regulatory Affairs Specialist in Albuquerque, NM
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
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Regulatory Affairs Specialist in Petaluma, CA
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
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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.
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