Talent.com
Regulatory Affairs Specialist [Remote eligible]
Regulatory Affairs Specialist [Remote eligible]MillenniumSoft • Tempe, ARIZONA
Regulatory Affairs Specialist [Remote eligible]

Regulatory Affairs Specialist [Remote eligible]

MillenniumSoft • Tempe, ARIZONA
30+ days ago
Job type
  • Full-time
  • Remote
Job description

Roles & Responsibilities

Essential job functions:

  • Understands and has working knowledge of European Medical Device Regulations.
  • Supports US and international product submissions/registrations, as needed.
    Participates in product core teams as required to ensure that the product is in compliance with all internal and external regulatory requirements.
  • Develops, documents and implements a regulatory strategy plan around remediation goals.
  • Initiates and updates regulatory registrations as required and per applicable SOPs.
  • Reviews and approves change orders for compliance with FDA, European and/or global regulations and standards.
  • Provides general support for regulatory team and special projects, as needed.
    Assists in the preparation of division procedures to ensure compliance with EU MDR, and other Regulatory and Corporate requirements.
  • Ensures adequate documentation of BDPI’s compliance to FDA, European and global regulations and standards.
  • Ensures maintenance of regulatory documentation.

Experience Required

  • A minimum of 3+ years employment in Regulatory Affairs, areas of product registration, compliance, or quality systems is preferred.
  • Experience with European Medical Device Regulations is preferred.
  • Experience with Kits and Procedure Packs is preferred.

Skills & Certifications

Basic qualifications

  • Excellent written and oral communication skills.
  • Proven computer skills (Microsoft Word, Excel, PowerPoint, Project, Outlook).
  • Demonstrated problem solving and analytical skills.
  • Ability to plan and schedule multiple priorities in a concurrent fashion.
  • Ability to review, collate and summarize scientific and technical data.
  • Detail-oriented, methodical, and able to handle regulatory information and
  • submissions with a high degree of accuracy.
  • Solid project management skills.
  • Experience working with others in a team environment.

Eligibilities & qualifications

Education and/or experience

  • This position requires a Bachelor’s degree or advanced degree in a technical area such as biology, chemistry, engineering or medical-related field.
Create a job alert for this search

Regulatory Affairs Specialist [Remote eligible] • Tempe, ARIZONA

Similar jobs

Work From Home - Product Specialist - $45 per hour

GL1Maricopa, Arizona
Remote
Part-time +1

Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies.We guarantee 15-25 hours per week with an hourly pay of bet...Show more

 • Promoted

Healthcare Counsel — Regulatory & Contracts Leader

Phoenix Children'sPhoenix, AZ, United States
Full-time

A leading pediatric health system in Phoenix, Arizona is seeking an Assistant General Counsel.The role requires at least five years of healthcare law experience, including regulatory compliance and...Show more

 • Promoted

Compliance Specialist

Concentric Healthcare StaffingScottsdale, Arizona, US
Full-time

Maintain regular cooperation and compliance with all regulatory, accrediting, and membership-based organizations.If the following job requirements and experience match your skills, please ensure yo...Show more

 • Promoted

Senior Analyst, UM Regulatory Operations

Oscar HealthTempe, AZ, United States
Full-time

Senior Analyst, UM Regulatory Operations.You will support the design, optimization, and implementation of processes and improvements to operations in support of achieving organizational goals.You w...Show more

 • Promoted

Consultant, Rates & Regulatory

Black & VeatchPhoenix, AZ, United States
Full-time +1

Consultant, Rates & Regulatory.Location: Overland Park, KS, US Atlanta, GA, US Houston, TX, US Tualatin, OR, US South Jordan, UT, US Dallas, TX, US Orlando, FL, US Tampa, FL, US Ann Arbor, MI, US J...Show more

 • Promoted

Client Solutions Manager

Slice Merchant ServicesParadise Valley, AZ, US
Full-time

Excellent opportunity to join a leading, national credit card processing company that has over a decade of industry experience.Slice Merchant Services offers innovative payment processing solutions...Show more

 • Promoted

Strategic Sourcing Specialist (Remote)

JLLPhoenix, AZ, AZ, United States
Remote
Full-time

This job is with JLL, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.Please do not contact the recruiter directly.JLL empowers you to ...Show more

 • Promoted

Remote Product Support Online - $25-$45 per hour

GLOCPAParadise Valley, Arizona
Remote
Part-time +1

Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies.We guarantee 15-25 hours per week with an hourly pay of bet...Show more

 • Promoted

Senior Quality and Compliance Specialist (Remote)

MMSPhoenix, AZ, US
Remote
Full-time
Quick Apply

About MMS MMS 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 sub...Show more

MRI Technologist

Simonmed ImagingMaricopa, AZ, US
Full-time

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protect...Show more

 • Promoted • New!

Travel Physical Therapist (PT) - $2,050 per week in Carefree, AZ

AlliedTravelCareersCarefree, AZ, US
Full-time

AlliedTravelCareers is working with Core Medical Group to find a qualified Physical Therapist (PT) in Carefree, Arizona, 85377!.Client in AZ seeking Physical Therapist.We are looking for a healthca...Show more

 • Promoted

Regulatory Affairs Specialist [Local & Remote eligible]

MillenniumSoft IncTempe, AZ, United States
Remote
Full-time

Eligibilities & Qualifications.Eligibilities & Qualifications.Show more

 • Promoted

Liquidity Regulatory Reporting Analyst, AVP

MUFGTempe, AZ, United States
Full-time

Join Mitsubishi UFJ Financial Group.Do you want your voice heard and your actions to count? Discover your opportunity with Mitsubishi UFJ Financial Group (MUFG), one of the world's leading financia...Show more

 • Promoted

Administrative Assistant - Part Time Panelists Needed - Remote

ApexFocusGroupAlhambra, Arizona, US
Remote
Full-time +1

Seeking participants for Focus Group and market research studies.Work part-time from home and earn up to $750 per week.Register to see if you are eligible.Administrative Assistant admin experience ...Show more

 • Promoted

Travel Nurse RN - Intensive Care Unit (ICU) / Critical Care - $2,132 to $2,368 per week in Northeastern Arizona, AZ

TravelNurseSourceNortheastern Arizona, AZ, US
Full-time

Registered Nurse (RN) | Intensive Care Unit (ICU) / Critical Care.Assist physicians with patient management.Provide patient care to patients.Collaborate with other disciplines to ensure effective a...Show more

 • Promoted

Remote Econometric Data Analyst (Stata SE)

Micro1Paradise Valley, Arizona, US
Remote
Full-time

Econometric Data Analyst (Stata SE).AI labs train foundational models and enterprises build AI agents.We provide frontier evaluations and reinforcement learning environments used to improve LLM cap...Show more

 • Promoted

Virtual Assistant: $11 - $22/HR

Data Entry JobsParadise Valley, AZ
Full-time +1

Virtual Assistant – Remote | Full-Time / Part-Time.We are looking for a proactive and organized Virtual Assistant to support our team with day-to-day administrative tasks.This is a fully remote pos...Show more

 • Promoted

Licensed Mental Health Therapist

LifeStance HealthMaricopa, AZ, US
Full-time +1

At LifeStance Health, we believe in a truly healthy society where mental and physical healthcare are unified to make lives better.Our mission is to help people lead healthier, more fulfilling lives...Show more