US Regulatory Affairs Operations Specialist
3 weeks ago
Title: US Regulatory Affairs Operations SpecialistLocation: St. Joseph, MO or Athens, GADuration: 18 MonthsPay rate: $56.00/hr on W2Part time role - 20 hours per week and requirement to be in the office 2-3 days a weekAnywhere between 08:00 am to 05:00 pm, Monday-Friday as scheduled.Duties: With minimum guidance, prepare high quality US regulatory submissions required by local and federal agencies to maintain products on the market. With minimum guidance and supervision prepare regulatory submissions for activities such as labeling supplements, DERs, EPA monthly and aggregate reports, drug product listing, establishment registration, advertising and promotional materials, product import, pesticide state adverse event reporting, state licensing renewals, state product renewals, and tonnage reporting. With minimum guidance and supervision, contribute to the development and implementation of processes and work instructions. Understand and monitor regulatory trends; understand and implement regulations and guidance. Interact with the authorities in a professional manner. Responsive to government agencies for questions on submissions. With minimum guidance and supervision, support systems for product compliance and maintenance.Skills: Strong requirement for proficiency in MS Office applications and Adobe Acrobat General knowledge in relevant Regulatory Affairs areas. General knowledge and understanding of regulatory legislation and requirements for the maintenance of veterinary products. General knowledge of the legal requirements for maintenance of veterinary medicinal products. Maintains compliance with respect to all requirements for assigned products. Ensures company interests are supported/maintained in negotiations with regulatory authorities resulting from requests and information received from regulatory authorities. Proficient in standard office technology, including Word, Excel, and Adobe Acrobat. Strong written and verbal communication skills Strong attention to detail Must exhibit good judgment, and ability to problem-solve issues in daily work. Demonstrated ability to successfully collaborate in a global organization and manage a full workload. Able to meet stringent time and quality demands. Self-motivated with a high degree of initiative, commitment and persistence. Well developed organizational capabilities. Strong team player who is collaborative with the mission of client, but able to drive change. AI Competencies Accountability: Taking ownership for decisions and actions. Agility: Quickly acting with an open mind to face internal and external circumstances. Intrapreneurship: Together with our customers, internal or external, creating innovative ideas to respond to changing needs.Education: Bachelor's degree and 1 year relevant industry experience OR Associate's degree and 3 years relevant industry experience OR In lieu of a degree, 5 years relevant industry experience including 1 year of related regulatory experience.
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Specialist, US Regulatory Affairs Operations
5 days ago
St Joseph, United States System One Holdings, LLC Full timeTitle: Regulatory Affairs Specialist Location: St. Joseph, MO OR Athens, GA Type: Contract Schedule: Monday-Friday Hours: 20 hours per week Joule has an opportunity that must be in the office 2-3 days a week at one of the above locations stated. With minimum guidance, the Specialist will be responsible to prepare high quality US regulatory submissions...
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Specialist, US Regulatory Affairs Operations
1 week ago
St Joseph, United States US Tech Solutions Full timeNote *Note the requirement to be in the office 2-3 days a week. *This is a part-time role (20 Hours/Week) Responsibilities: With minimum guidance, prepare high-quality US regulatory submissions required by local and federal agencies to maintain BI products on the market. With minimum guidance and supervision prepare regulatory submissions for activities such...
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Specialist, US Regulatory Affairs Operations
4 days ago
Saint Joseph, Missouri, United States System One Holdings, LLC Full timeTitle: Specialist, US Regulatory Affairs Operations (Part Time) Location: St. Joseph, MO Alternative location: Athens, GA Term: Contract - 07/01/2024 to 01/02/2026 Shift: Anywhere between 8 am to 5 pm, Monday-Friday as scheduled Hours: Part time | 20 hours per week Pay: Up to $58/hour (dependent on experience) *Note: Must be in the office 2-3 days a week....
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Regulatory Affairs Operations Specialist
5 days ago
St Joseph, United States Cynet Systems Full timeJob Description: With minimum guidance and supervision prepare regulatory submissions for activities such as labeling supplements, DERs, EPA monthly and aggregate reports, drug product listing, establishment registration, advertising and promotional materials, product import, pesticide state adverse event reporting, state licensing renewals, state product...
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Regulatory Affairs Specialist
6 days ago
St Paul, United States Experis Full timeOur client, is seeking a Regulatory Specialist to join their team. As a Regulatory Specialist, you will lead/ coordinate medical device and cosmetic regulatory affairs for part of the US designed portfolio Job Title: Regulatory Specialist Location: Remote (must be ableto work 8-5 EST or CST time zone) Pay Range: $25 to $35 p/h w-2 depending upon experience...
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Senior Regulatory Affairs Specialist
1 week ago
St Paul, United States Axelon Full timeTitle: Senior Regulatory Affairs Specialist Location: St Paul, MN Shift: 8:00 a.m - 5:00 p.m. Job Description: This position will be working with multiple business units to develop, update, and improve regulatory affair processes. Assist the strategy implementation and operations for regulatory affairs activities, including directing development of product...
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Senior Regulatory Affairs Specialist
3 weeks ago
St Paul, United States Axelon Full timeTitle: Senior Regulatory Affairs Specialist Location: St Paul, MN Shift: 8:00 a.m - 5:00 p.m. Job Description: This position will be working with multiple business units to develop, update, and improve regulatory affair processes. Assist the strategy implementation and operations for regulatory affairs activities, including directing development of...
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Regulatory Affairs Specialist
4 weeks ago
St Paul, United States Hemostasis Corp Full timeHemostasis, LLC designs, develops, manufactures, and markets advanced hemostat, wound healing technologies, and advanced medical devices for use in the healthcare industry. We are currently seeking a Regulatory Affairs Specialist that will be able to ensure compliance with regulations. Responsibilities Include: Communicate with regulatory agencies regarding...
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Regulatory Affairs Specialist
3 days ago
St Petersburg, United States Computech Corporation Full timeJob Title: Quality and Regulatory Affairs SpecialistLocation: OnsiteDuration: 6 months (with potential extension)Shift: Monday - Friday, 8 AM - 5 PM or 9 AM - 6 PMEducation and Experience:Education: Bachelors Degree in Science or a related field (Chemistry, Microbiology, or Biology).Experience: Minimum of 3 years in the pharmaceutical manufacturing industry...
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Regulatory Affairs Specialist
5 days ago
St Petersburg, United States Computech Corporation Full timeJob Title: Quality and Regulatory Affairs SpecialistLocation: OnsiteDuration: 6 months (with potential extension)Shift: Monday - Friday, 8 AM - 5 PM or 9 AM - 6 PMEducation and Experience:Education: Bachelor’s Degree in Science or a related field (Chemistry, Microbiology, or Biology).Experience: Minimum of 3 years in the pharmaceutical manufacturing...
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Regulatory Affairs Specialist
4 days ago
St Petersburg, United States Computech Full timeJob Title: Quality and Regulatory Affairs Specialist Location: Onsite Duration: 6 months (with potential extension) Shift: Monday - Friday, 8 AM - 5 PM or 9 AM - 6 PM Education and Experience: Education: Bachelor’s Degree in Science or a related field (Chemistry, Microbiology, or Biology). Experience: Minimum of 3 years in the pharmaceutical manufacturing...
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Regulatory Affairs Specialist
5 days ago
St. Petersburg, United States Computech Corporation Full timeJob Title: Quality and Regulatory Affairs SpecialistLocation: OnsiteDuration: 6 months (with potential extension)Shift: Monday - Friday, 8 AM - 5 PM or 9 AM - 6 PMEducation and Experience:Education: Bachelor’s Degree in Science or a related field (Chemistry, Microbiology, or Biology).Experience: Minimum of 3 years in the pharmaceutical manufacturing...
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Hybrid Position
3 weeks ago
Saint Joseph, United States InnoCom Full timeJob DescriptionJob DescriptionPosition: US Regulatory Affairs Operations SpecialistDuration: 18+monthsPay rate: $57/hr on w2 without benefitsLocation: Athens, GA or St Joseph, MOHours Per Day: 8.00 Hours Per Week: 20.00Duties:Preferred: St. Joseph, MO Alternative: Athens, GA *Note requirement to be in the office 2-3 days a week. Remote eligibleSkills:*Note...
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Senior Manager Regulatory Affairs
1 month ago
St Paul, United States Barrington James Full timeSenior Manager Regulatory Affairs - (Medical Device) - Hybrid in MN Our client is an, looking for a Senior Manager Regulatory Affairs with extensive experience with 510(k) submissions. As the Senior Manager Regulatory Affairs you will be the liaison for communication with US and international regulatory agencies for multiple submissions across the company....
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Regulatory Affairs Fellow
1 week ago
St Paul, United States Boston Scientific Full timeAt Boston Scientific, youll discover a place where you can find meaningful purpose, improving lives through your life's work. Global Regulatory Affairs Operations team is looking for a dynamic, well-organized leader who can be a contributing member Regulatory Affairs, Operations, Regulatory, Global, Operation, Fellow, Manufacturing, Business Services
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Senior Regulatory Affairs Specialist
1 month ago
St Paul, United States Collabera Full timeJob Description Job Description · Perform assigned regulatory activities including submissions/responses to country authorities. Daily Responsibilities - Job Description suppliers should use: · Plan and prepare documents for EU MDR Technical File original submissions or responses to Notified Body for existing Technical Files under review. · Assist in...
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Regulatory Affairs Manager
4 weeks ago
St Paul, United States Boston Scientific Full timeRecruiter: Spencer Gregory Hale Regulatory Affairs Manager - Core CRM Sustaining Program Regulatory POC Team Purpose: The Rhythm Management (RM) Regulatory Affairs leadership team is a strategic partner that delivers innovative, efficient, and sustainable business and regulatory solutions for customers throughout the product lifecycle. This role is...
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Regulatory Specialist
1 month ago
St Paul, United States Bell International Laboratories Full timeThe Regulatory Compliance Specialist, within the Quality Assurance department, is a dedicated professional who ensures adherence to regulatory compliance aligned with cGMP and current requirements. This individual aids in the day-to-day quality management activities within Bell Labs, ensuring alignment with both company and regulatory...
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Regulatory Specialist
4 weeks ago
St Paul, United States Bell International Laboratories Full timeThe Regulatory Compliance Specialist, within the Quality Assurance department, is a dedicated professional who ensures adherence to regulatory compliance aligned with cGMP and current requirements. This individual aids in the day-to-day quality management activities within Bell Labs, ensuring alignment with both company and regulatory requirements....
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Regulatory Specialist
3 weeks ago
St Paul, United States Bell International Laboratories Full timeThe Regulatory Compliance Specialist, within the Quality Assurance department, is a dedicated professional who ensures adherence to regulatory compliance aligned with cGMP and current requirements. This individual aids in the day-to-day quality management activities within Bell Labs, ensuring alignment with both company and regulatory...