Regulatory affairs manager Jobs in Scottsdale, AZ
Last updated: 9 hours ago
The Regulatory Affairs Specialist role is responsible for preparing and submitting the appropriate documentation for pre-market submissions (i.
FDA 510(k) submissions, Health Canada Medical Device L...Show moreLast updated: 11 days ago
Central Garden & Pet is a market leader in the Garden and Pet industries.For over 40 years, Central has proudly nurtured happy and healthy homes by bringing innovative and trusted solutions to its ...Show moreLast updated: 6 days ago
Are you passionate about making a difference in the world?.The Borgen Project is an international organization that works at the political level to improve living conditions for people impacted by ...Show moreLast updated: 9 hours ago
Represent Regulatory Affairs ("RA") on project teams and provide regulatory guidance.Review technical documents for cGMP and regulatory compliance.
Train and coach others in regulatory requirements....Show moreLast updated: 30+ days ago
Do you want your voice heard and your actions to count?.Discover your opportunity with Mitsubishi UFJ Financial Group (MUFG), the 7th largest financial group in the world.Across the globe, we’re 12...Show moreLast updated: 30+ days ago
Founded in 1968, Amkor pioneered the outsourcing of IC packaging and test and is now a strategic manufacturing partner for the world's leading semiconductor companies, foundries and electronics OEM...Show moreLast updated: 3 days ago
The Government Affairs Advisor is responsible for coordinating, implementing, and reporting on all ongoing government affairs activities that could have an impact on the Corporation at the local, s...Show moreLast updated: 30+ days ago
MOSDOH - Associate Dean, Academic Affairs.Still University's Missouri School of Dentistry and Oral Health (ATSU-MOSDOH) is seeking a full-time exempt Associate Dean, Academic Affairs.This position ...Show moreLast updated: 30+ days ago
As a Regulatory Compliance and Operational Risk Manager, you will get the opportunity to grow and contribute to our clients' business needs by providing in-depth technical knowledge on emerging reg...Show moreLast updated: 30+ days ago
Located conveniently in the heart of is a 571-bed, not-for-profit hospital that provides a wide range of health, social and support services.
Founded in 1895 by the Sisters of Mercy, St.Joseph's was...Show moreLast updated: 30+ days ago
![Regulatory Affairs Specialist [Remote eligible]](https://cdn-dynamic.talent.com/ajax/img/get-logo.php?empcode=millenniumsoft&empname=MillenniumSoft)
PayPal is committed to fair and equitable compensation practices.Actual Compensation is based on various factors including but not limited to work location, and relevant skills and experience.The t...Show moreLast updated: 30+ days ago
A company is looking for a Regulatory Affairs Manager- US Regulatory Lead.Key ResponsibilitiesEnsure acquisition and maintenance of licenses for clinical trials and commercially approved productsPl...Show moreLast updated: 8 days ago
Why You Should Apply for This Job .At Freeport-McMoRan, we are committed to providing employment that recognizes excellence and encourages safe production, with a culture supported by our core val...Show moreLast updated: 30+ days ago
With the right backing, people and businesses have the power to progress in incredible ways.When you join Team Amex, you become part of a global and diverse community of colleagues with an unwaveri...Show moreLast updated: 14 days ago
- Promoted
Regulatory Affairs Specialist
Innovative Health LLCScottsdale, AZ, USFull-time
- Promoted
Food Safety and Regulatory Affairs Manager
Central Garden & PetPhoenix, AZ, United States$95,000.00–$125,000.00 yearly
Full-time
- Promoted
- New!
Political Affairs Internship
The Borgen ProjectPhoenix, AZ, USPart-time +1
- Promoted
Senior Regulatory Specialist
Fresenius Kabi USA, LLCPhoenix, AZ, United States$103,241.25–$133,442.00 yearly
Regulatory Reporting Manager, Vice President
MUFGTempe, AZ$133,000.00–$164,000.00 yearly
Full-time
- Promoted
Director, State Government Affairs
Amkor Technology , Inc.Tempe, AZ, United StatesFull-time
Government Affairs Advisor
Southwest Gas CorporationPhoenix, AZ, United States$105,800.00–$158,700.00 yearly
- Promoted
MOSDOH - Associate Dean, Academic Affairs
InsideHigherEdMesa, ArizonaFull-time
Regulatory Compliance Risk Manager
Grant ThorntonPhoenix, AZ, United States$138,200.00–$207,400.00 yearly
Full-time
Project Manager Clinical Research Regulatory
St Joseph Hospital & Medical CenterPhoenix, AZFull-time
Manager, Managed Care Regulatory Filings
AmTrust FinancialScottsdale, AZ, US AmTrust Financial Services, a fast-growing commercial insurance company, has a need for a Manager, Managed Care Filings in one of our offices in FL, TX, NY, CA, or IL.
To support the Director of Uti...Show moreLast updated: 30+ days ago
Regulatory Affairs Specialist [Remote eligible]
MillenniumSoftTempe, ARIZONARegulatory Affairs Internship
Cynet SystemsTempe, AZ Provide general RA support for regulatory projects, under the direction of an RA professional.Effectively manage multiple competing priorities and work in a regulated environment.Assist with the co...Show moreLast updated: 30+ days ago
Senior Manager, Regulatory Relations
PayPalScottsdale, Arizona, United States of America$99,300.00–$216,040.00 yearly
Full-time
Manager Rates & Regulatory
Freeport-McMoRanPhoenix, AZ, US Share this Job Why You Should Apply For This Job : .Show moreLast updated: 30+ days ago
- Promoted
Regulatory Affairs Manager
VirtualVocationsScottsdale, Arizona, United StatesFull-time
Regulatory Affairs Manager
Tessenderlo GroupPhoenix, AZ, US Are you driven by a passion for agriculture and crop protection? Do you have a talent for navigating the complexities of regulatory affairs and product registration? If these resonate with you, we ...Show moreLast updated: 30+ days ago
Manager Rates & Regulatory
Freeport McMoRanPhoenix, AZ, US$123,000.00–$172,000.00 yearly
Senior Manager-Regulatory Change, Project Management Office
AMEXPhoenix, Arizona, United States$90,000.00–$165,000.00 yearly
Regulatory Affairs Specialist
Innovative Health LLCScottsdale, AZ, US11 days ago
Job type
- Full-time
Job descriptionMinimum of Bachelor's degree (preferably in technical field (i.e. engineering, medical)) or equivalent education, training and experience; Minimum of three (3) years medical device regulatory and / or quality experience; Knowledge and experience of FDA 21 CFR Part 820, and 510(k) submission requirements; Knowledge of Canadian Medical Device Regulations, MDD, MDSAP, ISO standards and filing regulatory submissions with Health Canada preferred; Detail oriented, with emphasis on accuracy and completeness; Strong critical thinking skills; Excellent organization, written and verbal communication skills; Ability to work in a fast paced / entrepreneurial team environment; Ability to work with changing priorities that involve multiple and concurrent projects; Ability to write technical documents (i.e procedures); Ability to recommend technical solutions; Ability to specify regulatory requirements for products; Ability to work with little supervision; Self-starter and highly motivated; Ability to use personal computers including software such as : Word, PowerPoint, Excel, Project and Minitab. This job operates in a clerical, office, as well as a manufacturing setting. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. While performing the duties of this job, the employee is frequently exposed to odors, fumes, dust or airborne particles, moving mechanical parts and vibration. The noise level in the work environment and job sites can be loud. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to sit; stand; walk; use hands and arms. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must occasionally lift and / or move up to 20 pounds.
Job Description
Job Description
The Regulatory Affairs Specialist role is responsible for preparing and submitting the appropriate documentation for pre-market submissions (i.e., FDA 510(k) submissions, Health Canada Medical Device License Applications) and documentation for other international regulatory bodies. This role also supports post-market regulatory compliance activities.
Essential Duties and Responsibilities :
- Write and lead the completion of high quality pre-market submissions;
- Review and verify documents / technical information for regulatory submissions from various functional areas and check for errors, legibility, and missing information;
- Review and approve protocols and reports to support regulatory submissions;
- Prepare or assist with preparation of additional information or responses as requested by regulatory agencies;
- Maintain and disseminate current knowledge base of existing regulations, standards, or guidance documents and proactively seek and find information to help resolve questions related to assigned projects;
- Participate in project development teams and review plans, reports, risk management, risk assessments and design reviews associated with product and process projects;
- Provide regulatory assessments for manufacturing, line extensions, design changes, and validation activities;
- Conduct regulatory review and approval of change orders, CAPA / nonconformance, and related project documentation;
- Review labeling and promotional material to ensure compliance with applicable regulations and policies;
- Implement and maintain unique identifier (UDI) activities for compliance;
- Assist with PFMEA risk assessments;
- Review complaints / adverse events for assessment of reportability and submission of MDRs if appropriate;
- Assist in archiving regulatory documentation and maintaining related databases;
- Participate in internal and external audits;
- Write or update standard operating procedures, work instructions or policies;
- Assist with coordinating recall or market withdrawal activities as necessary;
- Other duties as assigned.
Supervisory Responsibilities :
None
Education, Qualifications and Skills :
Work Environment :