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Regulatory affairs Jobs in Scottsdale, AZ

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Regulatory affairs • scottsdale az

Last updated: 3 days ago

Sr. Regulatory Affairs Specialist - Relocation Assistance Provided

Innovative Health LLCScottsdale, AZ, USA
Full-time
Quick Apply

Regulatory Affairs Specialist role is responsible for preparing and submitting the appropriate documentation for the submission of FDA 510(k)s, periodic updates, Canadian applications and registrat... Show more

Senior Regulatory Oversight Specialist

VanguardScottsdale, AZ, US
Full-time

The role will conduct effective and unbiased oversight supporting the Personal Investor’s product and service offerings.The oversight expands across both crew and direct leader duties to ensure com... Show more

Travel Pharmacist - $3,083 per week in Tuba City, AZ

AlliedTravelCareersMesa, Arizona, US
Full-time

AlliedTravelCareers is working with MedPro Healthcare Staffing to find a qualified Pharmacist in Tuba City, Arizona, 86045!.Joint Commission-certified staffing agency, is seeking a quality Pharmaci... Show more

 • Promoted

Remote Compliance / regulatory response with financial-services AI Evaluator - AI Trainer ($80-$120

MercorScottsdale, Arizona, US
$80.00 hourly
Remote
Full-time

About the role We are hiring expert Evaluators in **Compliance / regulatory response with financial-services AI** to review and assess AI-generated work products (documents, spreadsheets, and slide... Show more

Analyst, Regulatory Affairs

Oscar HealthTempe, AZ, United States
Full-time

We're hiring a Analyst, Regulatory Affairs to join our Regulatory Affairs team.Oscar is the first health insurance company built around a full stack technology platform and a relentless focus on se... Show more

Director, Federal & Regulatory Affairs

Grand Canyon State Electric Cooperative AssociationTempe, AZ, USA
$135,000.00 yearly
Full-time
Quick Apply

Grand Canyon State Electric Cooperative Association, Inc.Arizona's electric cooperatives formed Grand Canyon State Electric Cooperative Association Inc.Their primary purpose was to create a nonprof... Show more

Managing Technical Consultant, Permitting & Regulatory Specialist (Energy/Power/Renewable Projects)

Environmental Resources ManagementScottsdale, AZ, United States
$93,050.00 yearly
Temporary

Managing Technical Consultant, Permitting & Regulatory Specialist (Energy/Power/Renewable Projects).Are you ready to shape the next generation of renewable energy projects? At ERM, we're not just c... Show more

Managing Technical Consultant, Permitting & Regulatory Specialist (Energy/Power/Renewable Projects)

ERMScottsdale, AZ, United States
$93,050.00 yearly
Temporary

Managing Technical Consultant, Permitting & Regulatory Specialist (Energy/Power/Renewable Projects).Are you ready to shape the next generation of renewable energy projects? At ERM, we're not just c... Show more

Director, Engineering - Substation

AmpacityScottsdale, AZ, United States
Full-time

The Director of Engineering for Substation is a senior leadership role responsible for overseeing the planning, design, and implementation of Substation projects.This role involves managing a team ... Show more

CRA Regulatory Operations Manager

Salt River Pima-Maricopa Indian CommunityScottsdale, AZ, United States
Full-time

Under general supervision from the Director or Assistant Director of Gaming & Regulatory, assumes managerial control and responsibility over Gaming Agent staff at an assigned gaming facility.Ensure... Show more

RF Test Engineer for FCC - CE Regulatory Compliance

COMPLIANCE TESTING LLCMesa, AZ, US
$75,000.00–$150,000.00 yearly
Full-time +1
Quick Apply

Now Hiring ISO 17025 Regulatory Compliance RF Test Engineers TIC Industry aka.Testing, Inspection, FCC-CE Certification of Wireless & Connected Devices  Full or Part Time, Full Time or Ret... Show more

Sr. Director, RA

Becton DickinsonTempe, AZ, United States
Full-time

Regulatory Affairs (RA) Director.BD is one of the largest global medical technology companies in the world.Advancing the world of health is our Purpose, and it's no small feat.It takes the imaginat... Show more

Director of NERC Compliance

QE SolarScottsdale, AZ, United States
Full-time

Director, Nerc Compliance & CiP Programs.QE Solar is one of the nation's largest independent solar and BESS operations and maintenance providers, with over 15 years of operating experience.We manag... Show more

Regulatory Reporting AVP - Capital & Regulatory Reporting

MUFGTempe, AZ, United States
$87,000.00 yearly
Full-time

Assistant Vice President (AVP), Capital & Regulatory Reporting.Discover your opportunity with Mitsubishi UFJ Financial Group (MUFG), one of the world's leading financial groups.Across the globe, we... Show more

Regulatory Product Consultant

ITL USATempe, AZ, US
Full-time

Overview The Infosys Healthcare unit is dedicated to transforming the healthcare industry by leveraging cutting-edge AI-driven solutions to simplify complexities and enhance patient experiences.We ... Show more

Indirect Procurement Category Manager, Marketing

WaymoTempe, AZ, United States
$159,000.00 yearly
Full-time

Indirect Procurement Category Manager, Marketing.Waymo is an autonomous driving technology company with the mission to be the world's most trusted driver.Since its start as the Google Self-Driving ... Show more

Vice President - Data Science

Caris Life SciencesTempe, AZ, United States
Full-time

At Caris, we understand that cancer is an ugly worda word no one wants to hear, but one that connects us all.That's why we're not just transforming cancer carewe're changing lives.We introduced pre... Show more

Regulatory Affairs Specialist [Remote eligible]

MillenniumSoft IncTempe, AZ, United States
Full-time

Roles and responsibilities information is not provided in the raw HTML.Experience required information is not provided in the raw HTML.Skills and certifications information is not provided in the r... Show more

Project Manager

Biolab Holdings, IncMesa, US
Full-time

BioLab Holdings is a biotechnology company committed to raising the standard of caring by developing, manufacturing, and commercializing breakthrough products with patient care in mind.At the heart... Show more

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Sr. Regulatory Affairs Specialist - Relocation Assistance Provided

Sr. Regulatory Affairs Specialist - Relocation Assistance Provided

Innovative Health LLCScottsdale, AZ, USA
22 days ago
Job type
  • Full-time
  • Quick Apply
Job description

The Sr. Regulatory Affairs Specialist role is responsible for preparing and submitting the appropriate documentation for the submission of FDA 510(k)s, periodic updates, Canadian applications and registrations to regulatory agencies.

  • Responsible for managing and preparing 510(k) submissions to obtain FDA clearance to commercially distribute product.
  • Responsible for preparing Canadian applications to obtain approval to commercially distribute product.
  • Review and approve test protocols/reports and other documentation/information for regulatory submissions from various functional areas and check for errors, legibility, and missing information.
  • Prepare routine regulatory correspondence and assure submission to government agencies in support of marketed products.
  • Participate in project development teams and review plans, reports, risk management, and design reviews associated with product and process projects.
  • Assess necessity for submitting a 510(k) application by preparing regulatory assessments for manufacturing, line extensions, design changes, and validation activities. Prepare internal letter to File (US) for changes that do not require a 510(k) submission, and assess also for Canadian impact (i.e. application amendments).
  • 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.
  • Develop and maintain regulatory procedures and policies to ensure compliance to applicable regulations.
  • Reviews complaints/adverse events for submission of MDRs and Vigilance Reports.
  • Review and approve advertising/marketing material, and product labeling to ensure compliance with applicable regulatory requirements.
  • Participates in internal/external audits and responses to support audit findings or other respective actions related to such audits.
  • Conduct regulatory review and approval of engineering change orders, CAPA/nonconformance, and related project documentation.
  • Coordinate product correction and removals (recalls, market withdrawals, and stock retrievals) per procedures and applicable regulations.
  • Maintain Unique Device Identifier (UDI) activities for implementation/compliance.
  • Maintain regulatory registrations and product listings.
  • Assist in negotiations with the FDA or other regulatory agencies.
  • All other reasonable duties, as assigned.

Qualifications and Experience:

  • Bachelor's Degree in Life Science is preferred with a minimum of 8 years Regulatory experience in the Medical Device industry; or equivalent combination of education and experience;
  • Expert level knowledge of FDA 21 CFR Part 820 and 510(k) submission requirements;
  • Authoring of 510(k) submissions;
  • Experience and knowledge of Canadian Medical Device Regulations, MDSAP, and ISO Standards;
  • Experience with ToC format for Canadian applications, preferred;
  • Ability to work in a fast paced, collaborative team environment
  • Ability to handle multiple projects and coordinate with cross functional teams;
  • Ability to comfortably and effectively confront difficult situations and issues in a timely and appropriate manner while providing a solution;
  • Ability to recommend technical solutions;
  • Ability to specify regulatory requirements for products;
  • General proficiency in Microsoft Word and other applications (Excel, PowerPoint, Adobe Acrobat, and Visio).
  • Ability to work independently under general guidelines and supervision from the RA Manager.
  • Self-starter and highly motivated.