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Regulatory Affairs Jobs in Orlando, Orange, Florida

Senior Specialist, Regulatory Affairs
By H&H Group At Orlando, FL, United States
Good communication skills, strong project management ability and teamwork ability.
Familiar with the process of pet food export to China, experience in official certification documents works.
Salary and benefits will be competitive and commensurate with experience.
At least 1 year working experience in pet food
MOA registration program U.S. official documentation section
Label and advertising compliance review
Global Customer Experience Manager (Quality & Regulatory Affairs) - Remote
By Olympus Corporation of the Americas At , Westborough, Ma $106,692 - $149,366 a year
Experience and knowledge of all call center KPI & SL metrics.
Experience in driving change via business cases for transformation.
BA/BS in Business, communications. Equivalent years of experience in the business operation field and or medical device.
Experience of managing a critical path regarding customer complaints would be advantageous
Hands-on experience with service and support workflow tools such as ServiceNow, SFDC, Veeva, Oracle Zendesk.
Strong communication skills, expresses ideas fluently and logically, is open to input and can be depended on for truthfulness.
Lac Gov't Affairs Advisor
By FedEx Ground At Miami, FL, United States
Experience bridging between private and public on policy issues; direct government experience is a plus.
Exceptionally strong written and verbal communication skills, with ability to speak in public.
Influencing & Persuasion Skills, Judgement & Decision Making Skills, Networking Skills, Problem
Proactive mindset - ability to work in an exceedingly dynamic and fast-paced environment
Excels in simultaneously managing multiple projects and priorities
Highly motivated with keen attention to detail
Research Director/Regulatory Affairs Mngr
By Napa Research Center At Pompano Beach, FL, United States

Opportunity to advance career in clinical research company. Great financial compensation plan with healthcare benefits. Overlook responsibility of a great dedicated staff and be an integral part in ...

Regulatory Affairs Specialist (Remote)
By Zimmer Biomet At , Jacksonville, Fl $72,000 - $80,000 a year
A combination of education and experience may be considered
Evaluate risk of proposed regulatory strategies; may offer solutions
Writes and manages the development of package inserts
Strong writing, communication, and interpersonal skills
Knowledge of overall business environment, the orthopaedic industry, and the marketplace
Knowledge of FDA, EU, and other regulatory body regulations
Regulatory Affairs Specialist Jobs
By Escalate Sciences At Tampa, FL, United States
e. A Combination of background, education and experience can be considered.
Excellent communication skills (verbal and written) in English and preferable a second language (i.e. Spanish or Portuguese)
Identifies country specific Technical and/or Legal requirements and prepares documents to comply with country specific requirements.
Provides basic information to various departments regarding submission requirements and standards to facilitate efficient processing by agencies.
University/Bachelors degree or equivalent experience is required. Degree within atechnical related discipline is preferred.
Minimum of 4 years of related experience is preferred.
Regulatory Affairs Specialist(100% Remote) $95K
By CyberCoders At Miami, FL, United States
3-5+ years of professional OUS EUMDR Regulatory Affairs experience
Experience with Medical Device Reg Affairs for implantable
Working knowledge of 21 CFR 820, ISO 13485, MDD, EU MDR, and MDSAP
Full Benefits: Medical, Dental, Vision for employee and all dependents!
Bleeding Edge Technology = smart device to control pain relief!
Maintain licenses/registrations in existing territories
Regulatory Affairs Specialist (Eumdr) $90K Base (100% Remote)
By CyberCoders At Pompano Beach, FL, United States
3-5+ years of professional OUS EUMDR Regulatory Affairs experience
Experience with Medical Device Reg Affairs for implantable
Working knowledge of 21 CFR 820, ISO 13485, MDD, EU MDR, and MDSAP
Full Benefits: Medical, Dental, Vision for employee and all dependents!
Bleeding Edge Technology = smart device to control pain relief!
Maintain licenses/registrations in existing territories
Director Of Regulatory Affairs
By Trebla Talent At Greater Chicago Area, United States
Strong knowledge of current drug development regulations and guidelines including ICH, FDA and EMA guidelines; NDA experience is required.
Minimum of 10 years of experience across Regulatory Affairs or another transferrable function in biotech/pharma
Both clinical and CMC experience is desired
Bachelor’s degree is required; advanced degree is preferred.
A passion for the psychedelic and mental health industry
Director/Senior Director of Regulatory Affairs
Director Regulatory Affairs Jobs
By Altasciences At United States
Critical thinking skills and ability to acquire and apply knowledge quickly;
Lead, manage and prepare clinical trial submissions;
Lead, manage, prepare, and submit meeting requests and meeting information packages to health agencies;
Lead, manage, prepare, and submit controlled correspondence to regulatory agencies;
8+ years of regulatory experience in an industry setting;
Strong knowledge of drug development and regulatory policy;
Regulatory Affairs Manager Jobs
By Korn Ferry At Boston, MA, United States
5+ years of experience in regulatory affairs environment in nutrition industry.
Excellent knowledge of US and Canada Food Law - Regulations.
Korn Ferry has partnered with our client on their search for the role, Regulatory Affairs Manager.
Ensure compliance of product, ingredients, and claims.
Supply regulatory support for safety files and clinical trials/protocols in order to support R&D.
Vetting and approval of all public materials, including labelling.
Remote: Vice President Regulatory Affairs
By Shepherd Regulatory Search At United States
At least 15 years of Global Regulatory Affairs leadership experience.
Extensive knowledge of ICH, FDA, EMA, HSA, PMDA, MFDS, and international regulations/guidelines.
Provide global regulatory leadership supporting global development.
Proactively participate in the design of US and ex-US regulatory strategies for the development of precision oncology therapies.
Direct and negotiate submissions (IND, CTA, NDA, MAA etc..) and approvals with regulatory authorities.
Form partnerships across the Science Units to provide/facilitate provisions of the appropriate regulatory affairs advice to each area.
California Regulatory Affairs Analyst (Hybrid)
By California ISO At Folsom, CA, United States
Level of Education and Discipline:
Participate in paid on-call rotation and other job-related duties as assigned.
May perform related duties and activities as assigned.
Adheres to and supports the Core Values of the ISO.
Regulatory Affairs Associate Jobs
By Agilent Technologies At California, United States
Compile materials required in submissions, license renewal and annual registrations and maintains updated information about national/regional/global regulatory requirements.
Maintain and updates information about global regulatory requirements.
4+ years of Regulatory Affairs experience
Post-graduate and/or certification/ license may be required.
Review product labeling and marketing materials for accuracy and compliance with regulations.
Respond to customers and/or authorities requests/inquiries dealing with regulations and product compliance.
Regulatory Affairs Consultant (Freelance)
By Alien Technology Transfer At United States
Provide training to company managers and other relevant team members in areas related to regulatory compliance and associated best practices;
Conduct thorough research and stay up-to-date with US regulatory requirements, guidelines, and industry best practices pertaining to healthcare products and pharmaceuticals.
Minimum of 5 years of experience as a Regulatory Affairs Consultant in the healthcare industry, with a focus on US regulations;
In-depth knowledge of US FDA regulations and guidelines for drug and medical device development and approval processes;
Exceptional research, analytical, and problem-solving skills;
Excellent written and verbal communication skills;
Assistant Director Of Regulatory Affairs
By NC Real Estate Commission At West Bend, NC, United States

Attorney needed to assist division director with supervisory and managerial responsibilities and to prosecute cases involving allegations of violations of Real Estate License Law and Commission ...

International Regulatory Affairs Specialist
By Scholl's Wellness Company At Parsippany, NJ, United States

Seeking a part time International regulatory consultant to help manage International product registrations in select International markets Must be familiar with the International registration process ...

Regulatory Affairs Manager Jobs
By Jobot At New York, NY, United States
Strong knowledge of OTC drug and device regulations, including labeling requirements
Significant experience with U.S. drug and/or medical device regulatory submissions and maintenance; OTC preferred
Working knowledge of U.S. clinical research and claims support
Excellent written and verbal communication skills
6+ years of experience in U.S. and/or Canada pharmaceutical or medical device Regulatory Affairs
Drug or medical device submission and/or maintenance experience
Program Manager (Quality & Regulatory Affairs) - Remote
By Olympus Corporation of the Americas At United States
Excellent interpersonal skills and experience working with different personalities, cultures and levels of management.
Many years in complex projects or programs including first experience in portfolio management.
Strong analytical, multitasking, time management, and organizational skills with focused attention on detail.
Strong knowledge of project management concepts, tools, templates and methodologies and when to employ them.
Experienced in strategic planning and risk management.
MS Project and project management tools.
Regulatory Affairs Specialist Jobs
By Managed Staffing, Inc. At Austin, TX, United States
6. Support product change management, complete product claims reviews, labeling/ingredient reviews to ensure regulatory compliance.
The job description is detailed below:
Duration: 1+ year with possibility of extension
5. Provide consultation and guidance relative to the resolution of regulatory and/or quality issues and non-compliances
Vp Quality And Regulatory Affairs
By Proven Recruiting At San Diego, CA, United States
Management review of quality and regulatory team.
Manage the preparation and development of regulatory submission packages.
Oversee document control, internal and external audits, complaint system, CAPA, NCMRs, and key supplier qualifications.
Prior experience authoring and filing of regulatory documents.
Responsible for regulatory submission strategies to support product development and approval of various medical device products.
Interface with regulatory authorities and internal technical teams on regulatory submissions.
Vice President Regulatory Affairs
By Albion Rye Associates At United States
Offer strategic regulatory counsel to senior management.
Management of a large, global product portfolio with a demonstrated ability to manage a wide array of simultaneous activities.
You must have at least 15 years of managerial experience in the medical devices sector.
Head a skilled, diverse regulatory affairs team adept at navigating global regulations.
Devise and execute strategies for prompt global product launch while adhering to regulations.
Assure comprehensive and lawful post-launch product backing.
Regulatory Affairs Lead Jobs
By Bramwith Consulting At United States
Bachelors degree in a scientific discipline or relevant experience (post-graduate degree is preferred but not a requirement)
Experience working within US regulatory affairs within the pharmaceutical or healthcare industry
Experience of regulatory submissions and approvals, including new BLAs/NDAs
Experience with licensing including negotiating directly with the FDA
Salary - $150,000 to $160,000 plus excellent bonus and benefits
across their entire business. As part of this growth, the business is looking to hire an experienced
Rn - Registered Nurse - Quality Improvement - Regulatory Affairs - Am
By University of Alabama at Birmingham At , Birmingham

Pay Range: $60,835.00 - $98,855.00 / Year

Regulatory Affairs Manager Jobs
By Brunel At Dallas-Fort Worth Metroplex, United States
5+ years of progressive regualtory affairs experience
Submissions experience - EU and International markets
Oversee the regualtory function for full product portfolio, managing a team, department and budget
Coordinate regulatory submissions in US and OUS markets
Provide regulatory input/support for audits
Regulatory strategy for product development
Regulatory Affairs Strategist Jobs
By Navitas Life Sciences At , Remote
Develop and manage day-to-day operations using project management and planning tools, create and maintain detailed project timelines
Support delivery in performing project management activities or as an individual contributor for a deliverable, managing relationships with all stakeholders
Sound understanding of regulatory information management concepts and tools needed to perform regulatory operations priorities in support of all business areas
Ensure development programs are compliant with ICH regulatory requirements and all local country regulatory requirements
There is a travel requirement of up to 10%
Knowledge of IND/NDA/BLA submissions and life cycle submissions for the US market
Regulatory Affairs Lead Jobs
By Bramwith Consulting At Massachusetts, United States
Ensure sustained quality and efficiency through modern artwork management systems
Extensive experience working with Healthcare/Pharmaceutical product labelling
Consistently drive continuous improvement related to global Pharmaceutical labelling
Work highly cross-functionally with wider global teams, and educate global stakeholders of labelling best practices
Strong understanding of Pharmaceutical Regulatory Bodies across a global remit
Degree from a leading college