Current jobs related to Senior Regulatory Affairs Specialist - Jacksonville - ClinChoice
-
Senior Regulatory Affairs Specialist
4 months ago
Jacksonville, United States ClinChoice Full timeSenior Regulatory Affairs Specialist - Medical Devices (HYBRID ROLE) at ClinChoice (View all jobs) Jacksonville, Florida, United States Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds.... ...
-
Manager of Regulatory Affairs
4 months ago
Jacksonville, United States ClinChoice Full timeManager of Regulatory Affairs - Medical Devices (HYBRID ROLE) at ClinChoice (View all jobs) Jacksonville, Florida, United States Location: Jacksonville, FL or Irvine, CA - Hybrid (2 days per week from office) - HYBRID ROLE Schedule: Permanent ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent...
-
Manager, Regulatory Affairs
2 months ago
Jacksonville, United States LotSolutions, Inc. Full timeJob DescriptionJob DescriptionIn this role, you will review, research, gather information, and respond to reviews and complaints for U.S. insurers, service contract companies, motor clubs, agency entities, and SBAC. You will assist with mediation, arbitration, and litigation, while engaging directly with Departments of Insurance, Better Business Bureau,...
-
Physician Assistant
1 week ago
Jacksonville, Florida, United States Department of Veterans Affairs Full timeJob Summary:The Department of Veterans Affairs is seeking a highly skilled Physician Assistant to join our team. As a Physician Assistant, you will play a critical role in providing high-quality patient care and contributing to the achievement of quality care standards.Key Responsibilities:Provide care for Veteran patients, sometimes under the review and/or...
-
Regulatory Compliance Specialist
2 weeks ago
Jacksonville, Florida, United States VyStar Credit Union Full timePosition Overview:The Regulatory Compliance Specialist will assist VyStar's Compliance Management team in addressing various regulatory issues related to assigned subject matter areas. Key Responsibilities:- Address routine inquiries related to compliance matters.- Collaborate with team members to ensure adherence to compliance standards.- Conduct thorough...
-
Regulatory Control Senior Advisor
6 days ago
Jacksonville, Florida, United States Deutsche Bank Full timeJob Title: Regulatory Control Senior AdvisorAt Deutsche Bank, we are seeking a highly skilled Regulatory Control Senior Advisor to join our Surveillance Calibration & Effectiveness Review (SCE) team. As a key member of this team, you will play a critical role in providing observations and recommendations to optimize the effectiveness and efficiency of Trade...
-
Regulatory Compliance Specialist
2 months ago
Jacksonville, United States Swisher Hygiene Full timeSwisher is a leading lifestyle brand for adult consumers headquartered in Jacksonville, Florida. Our superior customer relationships, innovative thinking, and action have driven the company to grow and adapt for 160 years. The legendary company we are today is a result of our unrelenting drive to shape the experiences of tomorrow. As we shape the future, we...
-
Regulatory Compliance Specialist
3 weeks ago
Jacksonville, Florida, United States Jobs for Humanity Full timePosition Type:Full-timeType Of Hire:Experienced (relevant combination of work and education)Education Desired:Associate's DegreeTravel Percentage:0%Job Overview:As the world evolves rapidly, FIS is at the forefront of innovation. Our financial technology solutions impact nearly every market, organization, and individual globally. Our teams are diverse and...
-
Safety and Regulatory Compliance Specialist
1 week ago
Jacksonville, Florida, United States Flexible & Integrated Technical Services, LLC Full timeAbout the Role:We are seeking a highly skilled and experienced Safety and Regulatory Compliance Specialist to join our team at Flexible & Integrated Technical Services, LLC. As a key member of our Environmental Health and Safety (EHS) team, you will be responsible for ensuring compliance with regulatory requirements and developing and implementing...
-
Regulatory Risk Management Officer
3 weeks ago
Jacksonville, Florida, United States Citi Full timeThe Regulatory Risk Management Officer is a key strategic professional who remains informed about advancements within their field and contributes to the overarching strategy by applying their knowledge to their role and the organization. Recognized as a technical authority in a specific area within the organization, this role requires a foundational...
-
Nurse Practitioner
1 week ago
Jacksonville, Florida, United States Department of Veterans Affairs Full timeAbout the RoleWe are seeking an experienced and dynamic Advanced Practice Nurse to join our team at the Department of Veterans Affairs. As a Nurse Practitioner - Geriatrics Specialist, you will play a critical role in providing high-quality care to our veteran patients.Key ResponsibilitiesProvide comprehensive geriatric care to patients in community...
-
Customer Support Specialist
3 weeks ago
Jacksonville, Florida, United States Catalis Regulatory & Compliance, LLC Full timeAbout Catalis Regulatory & Compliance, LLC Catalis is a leading provider of software solutions for government agencies at all levels. Our innovative platform streamlines processes, enhances efficiency, and improves the delivery of public services. We are committed to leveraging technology to make government interactions simpler, faster, and more...
-
Licensed Practical Nurse
16 hours ago
Jacksonville, Florida, United States Legend Senior Living Full timeLegend Senior Living: A Leader in Senior CareWe are proud to be recognized as a Certified Great Places to Work 5 years in a row. Our commitment to excellence is reflected in our team's dedication to providing exceptional care to our residents.About the RoleWe are seeking an experienced Licensed Practical Nurse to join our nursing team as a Senior Care...
-
Vice President of Legal Affairs
2 weeks ago
Jacksonville, Florida, United States Wounded Warrior Project Full timeAbout the RoleWe are seeking a highly skilled and experienced Vice President of Legal Affairs to join our team at Wounded Warrior Project. As a key member of our executive team, you will be responsible for providing strategic legal guidance and counsel to our organization.Key Responsibilities Serve as the principal legal advisor to our CEO, Chairman of the...
-
Regulatory Compliance Specialist
3 weeks ago
Jacksonville, Florida, United States Nymbus, Inc. Full timeJob OverviewABOUT Nymbus, Inc.:Nymbus, Inc. stands at the forefront of financial technology, driven by a collective of innovators dedicated to transforming the banking landscape. Our state-of-the-art core platform and cloud solutions empower financial institutions to modernize and thrive in a competitive market.Joining us means becoming a pivotal part of a...
-
Regulatory Compliance Specialist
3 weeks ago
Jacksonville, Florida, United States Nymbus, Inc. Full timeJob OverviewABOUT Nymbus, Inc.:Nymbus, Inc. stands at the forefront of financial technology, fostering a community of innovators dedicated to transforming the banking landscape. Our award-winning modern core platform and cloud-based solutions empower financial institutions to modernize and thrive.As part of our team, you will not only participate in a...
-
Vice President of Academic Affairs
3 weeks ago
Jacksonville, Florida, United States Expert Education Consultants Full timePosition Title: Vice President of Academic AffairsInstitution Overview:Expert Education Consultants is a pioneering educational institution dedicated to establishing a new university in the Jacksonville area, aiming for licensing and accreditation within the next few years.Job Summary:As the Vice President of Academic Affairs, you will take on the role of...
-
Regulatory Control Senior Advisor
6 days ago
Jacksonville, Florida, United States Deutsche Bank AG Full time{"h1": "Regulatory Control Senior Advisor Job Description", "p": "At Deutsche Bank AG, we are seeking a highly skilled Regulatory Control Senior Advisor to join our Surveillance Calibration & Effectiveness Review (SCE) team. As a key member of this team, you will provide observations and recommendations to optimize the effectiveness and efficiency of Trade...
-
Regulatory Compliance Specialist
3 weeks ago
Jacksonville, Florida, United States Nymbus, Inc. Full timeJob OverviewABOUT Nymbus, Inc.:Nymbus, Inc. stands at the forefront of financial technology, fostering a culture of innovation aimed at transforming the banking landscape. Our cutting-edge core platform and cloud solutions empower financial institutions to modernize and thrive in a competitive environment.Joining us means becoming a catalyst for change. If...
-
Physician Assistant
7 days ago
Jacksonville, Florida, United States Department of Veterans Affairs Full timeJob SummaryWe are seeking a highly skilled and experienced Physician Assistant to join our team at the Department of Veterans Affairs. As a Physician Assistant, you will play a vital role in providing high-quality patient care and contributing to the achievement of quality care standards.Key ResponsibilitiesProvide care for Veteran patients, sometimes under...
Senior Regulatory Affairs Specialist
4 months ago
Position: Senior Regulatory Affairs Specialist
Employment type: 1 year Contract/ Permanent
Location: Jacksonville, FL or Irvine CA - 2 days per week
In order to make an application, simply read through the following job description and make sure to attach relevant documents.
ClinChoice is a global CRO that offers high-quality one-stop service to biopharmaceutical, medical device, and consumer products clients. Some of these services include clinical operations, project management, biostatistics, data management, regulatory affairs, medical affairs, and pharmacovigilance. ClinChoice has established major delivery centers across the US, Canada, China, Europe, India, Japan, and the Philippines. It has over 4,000 employees globally, with a strong and talented team, and a growing clinical operations presence in seven countries across Asia, North America, and Europe.
POSITION SUMMARY
Guided by supervision, the individual in this role provides regulatory support in a number of areas, including but not limited to:
A. Reviewing/analyzing modifications to product, manufacturing process, packaging, etc. to determine impact of registration status of approved products and to determine appropriate regulatory pathway.
B. Reviewing and approving advertising and promotion materials
C. Performing re-registration activities to support registrations Outside of the United States (OUS)
D. Assisting in developing regulatory strategies for new product development initiatives.
E. Performing regulatory operations tasks including archiving/assembling/publishing regulatory filings and other health authority communications.
Adheres to environmental policy, procedures, and supports department environmental objectives.
ESSENTIAL FUNCTIONS / RESPONSIBILITIES
Under supervision, the Senior Regulatory Affairs Specialist will be responsible for:
A. Coordinating and submitting registrations for maintenance of existing products, including international registrations, updates to Technical Documentation Files, Declarations of Conformity, etc.
B. Reviewing engineering/device change requests.
C. Researching, collecting data, responding to requests from regulatory agencies to prepare and submit documentation for US and OUS marketing clearances/approvals, as well as to provide routine information to business associates and their affiliates.
D. Provides regulatory guidance to various internal teams/department personnel and responds to regulatory related product requests.
E. Represents the regulatory affairs department in cross-functional project teams, plans and schedules regulatory deliverables to achieve project milestones.
F. Prepares associated product labeling to meet registration requirements for new or modified products; reviews product labeling associated with existing product to ensure compliance to regulatory requirements.
G. Assists in development of best practices, work instructions for Regulatory Affairs processes and
H. Provides Regulatory Affairs support for internal and external quality system audits.
QUALIFICATIONS
Minimum education required for competent performance:
Bachelor’s Degree - Scientific Discipline (preferred)
Minimum of 3 years of work experience within the Medical Device or Pharmaceutical industry or 0-3 years with a PharmD/PhD. Strong communication, organizational, negotiation and interpersonal skills
General knowledge, understanding and application of principles, concepts and practices related to FDA regulations. Regulatory knowledge to maintain legal status of products and minimize risk. Broad based technical knowledge and skills in diverse business functions (e.g., R&D, Operations, QA, laboratories, marketing, etc.) are a plus. Self-motivated and committed to a team focused approach to problem solving. Ability to organize and analyze technical data and identify issues or gaps. Ability to provide innovative solutions within the boundaries of regulation.
ClinChoice is an Equal Opportunity Employer / Committed to Diversity
