![ClinChoice Inc.](https://media.trabajo.org/img/noimg.jpg)
Senior Regulatory Affairs Specialist
1 month ago
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 its the best of both worlds.
ClinChoice is searching for a
Senior Regulatory Affairs Specialist (Medical Devices)
Consultant to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the clients counterparts.
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:
Bachelors 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.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.
The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-PR1 #LI-Hybrid #Contract
#J-18808-Ljbffr
We have other current jobs related to this field that you can find below
-
Senior Regulatory Affairs Specialist
3 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.... ...
-
Senior Regulatory Affairs Specialist
1 month 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.... ClinChoice...
-
Senior Regulatory Affairs Specialist
2 months ago
Jacksonville, United States ClinChoice Full timeAre 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.... ClinChoice is searching for a Senior Regulatory Affairs Specialist (Medical Devices) Consultant to join one of our clients. ClinChoice is a global...
-
Manager of Regulatory Affairs
2 weeks 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 work-life...
-
Manager of Regulatory Affairs
3 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
4 weeks 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,...
-
Regulatory Specialist
1 week ago
Jacksonville, United States Kelly Science, Engineering, Technology & Telecom Full timeKelly Science and Clinical FSP is currently seeking a Regulatory Specialist - Registration Lead for a long-term engagement in Jacksonville, FL with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time...
-
Principal Regulatory Strategist
4 weeks ago
Jacksonville, United States MMS Full timeJob DescriptionJob DescriptionMMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable...
-
Principal Regulatory Strategist
2 months ago
Jacksonville, United States MMS Full timeJob DescriptionJob DescriptionMMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable...
-
Regulatory Compliance Specialist
3 weeks ago
Jacksonville, United States Swisher Hygiene Inc 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, 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...
-
Senior Agency Compliance Specialist
1 month ago
Jacksonville, United States Olympus Insurance Company Full timeJob Title: Senior Agency Compliance Specialist Reports to: Agency Operations Manager Direct Reports: None Location: Jacksonville Office Location Position type: Full Time Business Hours of Operation: Monday-Thursday, 8:00AM-6:00PM and Friday, 8:00AM-5:00PM ********THIS POSITION IS IN OFFICE********* Job Summary The Senior Agency Compliance Specialist ensures...
-
Senior Clinical Engineer
2 months ago
Jacksonville, United States TalentHubb Full timeWe are seeking a highly skilled and experienced Senior Clinical Development Engineer to join our dynamic team. The Senior Clinical Development Engineer will play a crucial role in the research and development of medical devices, ensuring compliance with regulatory standards and user/clinical requirements. This position requires strong analytical skills,...
-
Senior Clinical Engineer
2 months ago
Jacksonville, United States TalentHubb Full timeWe are seeking a highly skilled and experienced Senior Clinical Development Engineer to join our dynamic team. The Senior Clinical Development Engineer will play a crucial role in the research and development of medical devices, ensuring compliance with regulatory standards and user/clinical requirements. This position requires strong analytical skills,...
-
Tax Operations Specialist
1 month ago
Jacksonville, United States The Adecco Group Full timeAdecco is currently looking for a Tax Operations Specialist to join our team! As a Senior Operations Representative, you will be pivotal in supporting tax-related functions, including IRS and State regulatory reporting, withholding payments, and cost Operations Specialist, Tax, Operations, Specialist, Data Entry, Manufacturing, Staffing
-
Senior Project Cost Specialist
4 weeks ago
Jacksonville, United States SGS Technologie Full timePosition Title - Senior Project Cost Specialist Location: Jacksonville, FLDuration: 12+ monthsSummaryThis senior role leads and trains others in project cost forecasting, estimating, budgeting, and documentation for utility construction projects. You'll ensure an efficient, accurate, and complete project cost process. The position requires a strong...
-
Senior Project Cost Specialist
4 weeks ago
Jacksonville, United States SGS Technologie Full timePosition Title - Senior Project Cost Specialist Location: Jacksonville, FLDuration: 12+ monthsSummaryThis senior role leads and trains others in project cost forecasting, estimating, budgeting, and documentation for utility construction projects. You'll ensure an efficient, accurate, and complete project cost process. The position requires a strong...
-
Immigration Specialist II
1 month ago
Jacksonville, United States University of Florida Full timeJob Description: Coordinates the UFCOM-J immigration petitioning to sponsor foreign nationals for H-1B, TN, O1, and E-3 and J-1 nonimmigrant statuses, green card process, as well as waiver process and files for Conrad Waiver and SCRC’s etc.. Evaluates information provided on all nonimmigrant petitions, initiates the actions within the Fragomen Law...
-
AF Solutions: Senior Clinical Specialist
1 month ago
Jacksonville, United States Boston Scientific Full timeThe AF Solutions Clinical Specialist will promote and support the Watchman product line through education of current and potential customers within a defined area. The clinical will provide clinical education, sales strategy and support in order to a Clinical, Solutions, Specialist, Clinical Research, Senior, Technical Support, Manufacturing
-
Senior Recovery Resolution Specialist
4 weeks ago
Jacksonville, Florida, United States First Citizens Bank Full timeThe Senior Recovery Resolution Specialist collects retail and business loans that have been placed in charge-off status at an advanced recovery rate.Works closely with borrowers, management, and attorneys to create action plans for delinquent loans, coordinating settlements or liquidation of assets as necessary.This position will be focused on bankruptcy and...