Regulatory Affairs Specialist jobs in Boca Raton, 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
  • Confidential
  • Boca Raton, FL FULL_TIME
  • The Company is a small public company based in Boca Raton, operating in two divisions. Medical Devices: Surgical device marketed in the US, Europe and a range of other countries internationally. The division has ISO 13485 and MDSAP, FDA 510(k) clearance (Class II), CE Mark (Class III, MDD) and other regulatory approvals internationally. Medical Therapies: vision therapies (software) with FDA 510(k) clearance or exemption marketed in the US and with CE Mark (Class I) marketed in Europe from Boca and with a European partner.

    The Company handles responsibility for US, EU, Canada and ISO/MDSAP itself. In other international markets it generally appoints its local distributor to be its authorized representative, responsible for regulatory affairs

    The Company is seeking a Regulatory Affairs and Quality Affairs person to be responsible for all aspects of the Company’s regulatory matters, reporting directly to the CFO (who has overall Regulatory responsibility), the President (who has responsibility for Quality and manufacturing) and the CEO. This primarily involves the US (FDA), EU (CE Mark) and ISO/MDSAP, so working knowledge of FDA, European regulatory affairs and requirements and ISO/MDSAP is preferred.

    Responsibilities include:

    · Overall responsibility for the company’s compliance with relevant FDA, CE Mark, ISO and MDSAP requirements.

    · Overall responsibility for maintaining all regulatory documentation and records, including device databases (GUDID, Eudamed, etc.).

    · Supporting other international authorized representatives with regulatory requests and filings.

    · Handling internal and external audits together with the CFO.

    · Handling day-to-day QA/RA matters such as customer complaints, CAPAs etc., product incoming inspections, maintenance of records.

    · Continual review and refinement of the Quality Management System (QMS), SOPs etc., and ensuring they are applied and followed.

    · Handling the regulatory aspects of new and existing product development, in conjuction with outside consultants.

    · Conducting and documenting Management Reviews and other required regular updates/reviews. Managing annual key supplier assessments. Coordinating post-market surveillance activities.

    · Responsible for ensuring staff training in regulatory matters is kept up to date.

    Job Requirements

    · In office role, 8.30am to 5.30pm.

    · Candidates seeking a fixed part-time role (less than 40 hours/week) will be considered.

    · Bachelor’s Degree.

    · Min 1-3 years experience in medical device regulatory/quality affairs required.

    · Excellent organizational, research, verbal and written skills, be detail-oriented and able to multi-task effectively and meet deadlines.

    Job Type: Full-time

    Pay: $55,000.00 - $70,000.00 per year

    Benefits:

    • 401(k)
    • Dental insurance
    • Health insurance
    • Paid time off
    • Vision insurance

    Experience level:

    • 2 years

    Schedule:

    • Monday to Friday

    Education:

    • Bachelor's (Required)

    Work Location: In person

  • 5 Days Ago

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Regulatory Affairs Coordinator
  • Jupiter Medical Center, Inc.
  • Jupiter, FL FULL_TIME
  • Ranked #1 for Safety, Quality and Patient Satisfaction, Jupiter Medical Center is the leading destination for world-class health care in Palm Beach County and the greater Treasure Coast. Outstanding p...
  • 1 Day Ago

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Senior Manager, Regulatory Affairs
  • ADMA BIOMANUFACTURING LLC
  • Boca Raton, FL OTHER
  • Job Details Job Location: ADMA Biologics - Boca Raton, FL Salary Range: Undisclosed Job Shift: Day DescriptionADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior ...
  • 16 Days Ago

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Regulatory specialist
  • State of Florida
  • Beach, FL FULL_TIME
  • Requisition No : 824337 Agency : Business and Professional Regulations Working Title : REGULATORY SPECIALIST III - 79001094 Pay Plan : Career Service Position Number : 79001094 Salary : $ 1,531.54 Biw...
  • 22 Days Ago

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Regulatory specialist
  • My Florida Corp Defunct
  • Beach, FL FULL_TIME
  • REGULATORY SPECIALIST III - 79001094 Date : Mar 1, 2024 Location : WEST PALM BEACH, FL, US, 33401 WEST PALM BEACH, FL, US, 33405 WEST PALM BEACH, FL, US, 33406 WEST PALM BEACH, FL, US, 33407 WEST PALM...
  • 23 Days Ago

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Associate Director, Regulatory Affairs - Plasma Services
  • ADMA BIOMANUFACTURING LLC
  • Boca Raton, FL OTHER
  • Job Details Job Location: ADMA Biologics - Boca Raton, FL Salary Range: Undisclosed Travel Percentage: Up to 50% Job Shift: Day DescriptionADMA Biologics is a biopharmaceutical company relentlessly co...
  • 3 Days Ago

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0 Regulatory Affairs Specialist jobs found in Boca Raton, FL area

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Strategic Finance Associate
  • Korn Ferry
  • Pembroke Pines, FL
  • Our client is a Private Equity backed business committed to driving innovation in today's dynamic business landscape. As...
  • 3/28/2024 12:00:00 AM

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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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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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Junior Financial Analyst
  • BrandStar
  • Pompano Beach, FL
  • Job Description Dynamic and fast-growing Marketing and Media company seeking candidates to join our accounting departmen...
  • 3/25/2024 12:00:00 AM

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Associate Personal Banker Delray Beach
  • WELLS FARGO BANK
  • Delray Beach, 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...
  • 3/25/2024 12:00:00 AM

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Wealth Advisor III
  • Tompkins Community Bank
  • Delray Beach, FL
  • Overview: Responsible for maintaining existing client relationships and growing their portfolio by building new client r...
  • 3/25/2024 12:00:00 AM

S
VP of Finance
  • Spring Footwear Corp
  • Pompano Beach, FL
  • Job Description Spring Footwear Corp. has been in business since 1991 and we have enjoyed tremendous growth. We deliver ...
  • 3/25/2024 12:00:00 AM

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Patient Financial Associate, Patient Access Boca Raton, $1,000 Bonus, FT, 3P-11:30P
  • Baptist Health South Florida
  • Boca Raton, FL
  • Applies only to Emergency Department and BOS Digital Registration. Responsible for completing varied duties to support t...
  • 3/24/2024 12:00:00 AM

According to the United States Census Bureau, the city has an area of 29.1 sq mi (75.4 km2), of which 27.2 sq mi (70.4 km2) of this is land and 1.9 sq mi (5.0 km2) of it (6.63%) is water. Boca Raton is a "principal city" (as defined by the Census Bureau) of the Miami metropolitan area. Approximately 1 sq mi is on the barrier island Deerfield Beach Island (DBI), also colloquially known as Deerfield Cay. Like other South Florida cities, Boca Raton has a water table that does not permit building basements, but there are several high points in the city, such as 4th Avenue which is aptly named "Hig...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$74,506 to $99,848
Boca Raton, Florida area prices
were up 1.5% from a year ago

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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.
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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.
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