Senior Regulatory Specialist-Medical

2 weeks ago

Minneapolis, United States Manpower Engineering Full time

Our client in cross-domain solutions is seeking a Sr. Regulatory Specialist to join their team. As a Regulatory Specialist, you will be part of the Neuromodulations business unit supporting the medical implant team. The ideal candidate will have a Master's Degree in Biomedical Engineering (or equivalent), related medical writing experience, and experience in medical device regulatory affairs which will align successfully in the organization.

Job Title: Sr. Regulatory Specialist

Location: Fountain Inn, South Carolina

Pay Range: $50-65/hour

What's the Job?
•Responsible for regulatory authority queries on Technical file or submissions.
•Maintains a continued awareness and understanding of EU and FDA regulations and guidance documents.
•Prepare regulatory submissions assigned (EU Technical file, notification of change, pre-submissions, IDE & IDE Supplements, etc.)
•Direct interface with the International Regulatory Agencies on assigned projects.
•Perform regulatory assessments of changes as part of the change management process.

What's Needed?

  • Minimum of a master's degree in biomedical engineering, science or equivalent technical discipline and at least 6 years of previous related experience in medical writing and medical device regulatory affairs;
  • o Demonstrated experience in the development, writing and editing of regulatory/ clinical submissions (e.g. FDA PMA applications, IDE Progress Reports, EU technical files)
    o Understanding in US and EU regulatory requirements in medical device.
What's in it for me?
  • Great company culture
  • Experience working for an established industry leader
If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you

About ManpowerGroup, Parent Company of:Manpower, Experis, Talent Solutions, and Jefferson Wells

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands - Manpower, Experis, Talent Solutions, and Jefferson Wells - creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Minneapolis, Minnesota, United States Philips North America Full time

    Job Title: Senior Regulatory Affairs Specialist About the Job: As a Senior Regulatory Affairs Specialist at our company, you will have the exciting opportunity to prepare comprehensive regulatory strategies and filings for both new and legacy devices, communicate these strategies effectively, and collaborate with internal stakeholders and regulatory agencies...

  • (2) Regulatory Specialist 2

    1 month ago

    Minneapolis, United States Custom Search Full time

    Our mid-sized client is adding a Regulatory Affairs Specialist 2 to join their team. The Regulatory Affairs Specialist will support international registrations and renewals. This individual is responsible for ensuring product approvals are properly maintained, and product re-registrations are properly managed. The Regulatory Affairs Specialist will perform...

  • Senior Regulatory Affairs Specialist

    4 weeks ago

    Minneapolis, United States Philips North America Full time

    Job TitleSenior Regulatory Affairs Specialist Job Description Looking at the challenges the world is facing today Philips purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, youll be working towards creating a better and fairer future for all. In this role you have the opportunity to You will prepare...

  • Advanced Regulatory Affairs Specialist

    4 weeks ago

    Minneapolis, United States Bio-Techne Full time

    Job Details Level: Experienced Job Location: Minneapolis MN - Minneapolis, MN Position Type: Full Time Education Level: Bachelor's Degree Salary Range: Undisclosed Travel Percentage: Negligible Job Shift: Day Job Category: Quality & Regulatory Description By joining the Bio-Techne team, you will have an impact on future cutting-edge research....

  • Advanced Regulatory Affairs Specialist

    4 weeks ago

    Minneapolis, United States Bio-Techne Full time

    **By joining the Bio-Techne team, you will have an impact on future cutting-edge research. Bio-Techne andall ofits brands provides tools for researchers in Life Sciences and Clinical Diagnostics.** **Position Summary:** The Advanced Regulatory Affairs Specialist provides independent support to senior regulatory staff to submit regulatory filings. This...

  • Regulatory Policy Specialist

    1 month ago

    Minneapolis, Minnesota, United States Xcel Energy Full time

    Are you looking for an exciting job where you can put your skills and talents to work at a company you can feel proud to be a part of? Do you want a workplace that will challenge you and offer you opportunities to learn and grow? A position at Xcel Energy could be just what you're looking for.Position SummaryWork directly with senior management to develop...

  • Regulatory Compliance Specialist

    7 days ago

    Minneapolis, United States Murtech Full time

    Job DescriptionJob DescriptionPosition: Compliance SpecialistLocation: Minneapolis, MN (onsite)Duration: 6-month W2 contractDescription:The Compliance Specialist is responsible for participating in governance processes that ensure compliance with chemical substance registration regulations across the globe. Responsibilities: Work on a team that provides a...

  • Regulatory Compliance Specialist

    5 days ago

    Minneapolis, United States MURTECH STAFFING AND SOLUTIONS, LLC Full time

    Position: Compliance Specialist Location: Minneapolis, MN (onsite) Duration: 6-month W2 contract Description: The Compliance Specialist is responsible for participating in governance processes that ensure compliance with chemical substance registration regulations across the globe. Responsibilities: Work on a team that provides a full spectrum of...

  • Regulatory Compliance Specialist

    7 days ago

    Minneapolis, United States MURTECH STAFFING AND SOLUTIONS, LLC Full time

    Position: Compliance SpecialistLocation: Minneapolis, MN (onsite)Duration: 6-month W2 contractDescription:The Compliance Specialist is responsible for participating in governance processes that ensure compliance with chemical substance registration regulations across the globe. Responsibilities: Work on a team that provides a full spectrum of chemical...

  • Regulatory Compliance Specialist

    5 days ago

    Minneapolis, United States MURTECH STAFFING AND SOLUTIONS, LLC Full time

    Position: Compliance SpecialistLocation: Minneapolis, MN (onsite)Duration: 6-month W2 contractDescription:The Compliance Specialist is responsible for participating in governance processes that ensure compliance with chemical substance registration regulations across the globe. Responsibilities: Work on a team that provides a full spectrum of chemical...

  • Senior Compliance Specialist

    2 weeks ago

    Minneapolis, Minnesota, United States Bridgewater Bank Full time

    Senior Compliance Specialist at Bridgewater BankWe are looking for a detail-oriented Senior Compliance Specialist to join our team at Bridgewater Bank in St. Louis Park.Responsibilities:Conduct scheduled monitoring/review activities for loans, deposits, and compliance requirementsCommunicate with various levels of staff and draft reportsManage compliance...

  • technical file specialist

    2 weeks ago

    Minneapolis, United States Randstad Full time

    technical file specialist. minneapolis , minnesota posted june 4, 2024 job details summary $75 - $83 per hour contract bachelor degree category computer and mathematical occupations reference1054317 job details job summary: Position Summary: The Senior Technical File Specialist will lead creation of EU MDR technical file, review product...

  • Senior Compliance Specialist

    4 weeks ago

    Minneapolis, United States Bridgewater Bank Full time

    We are seeking a meticulous and organized Sr. Compliance Specialist to join our Compliance team at our St. Louis Park location. Reporting to the Compliance Manager, the Senior Compliance Specialist provides support in the development and administration of the Bank's compliance program and second line of defense. Under minimal supervision, this position will...

  • Senior Compliance Specialist

    3 weeks ago

    Minneapolis, United States Bridgewater Bank Full time

    We are seeking a meticulous and organized Sr. Compliance Specialist to join our Compliance team at our St. Louis Park location. Reporting to the Compliance Manager, the Senior Compliance Specialist provides support in the development and administration of the Bank's compliance program and second line of defense. Under minimal supervision, this position will...

  • Manager, Regulatory Policy

    1 week ago

    Minneapolis, Minnesota, United States Xcel Energy Full time

    Are you looking for an exciting job where you can put your skills and talents to work at a company you can feel proud to be a part of? Do you want a workplace that will challenge you and offer you opportunities to learn and grow? A position at Xcel Energy could be just what you're looking for.Position SummaryDetermine the appropriate policy direction...

  • Medical Office Specialist Senior, Fam

    7 days ago

    Minneapolis, Minnesota, United States Hennepin County Medical Center Full time

    Hennepin Healthcare is an integrated system of care that includes HCMC, a nationally recognized Level I Adult Trauma Center and Level I Pediatric Trauma Center and acute care hospital, as well as a clinic system with primary care clinics located in Minneapolis and across Hennepin County. The comprehensive healthcare system includes a 473-bed academic medical...

  • Medical Billing Specialist

    3 weeks ago

    Minneapolis, United States Home Health Care Full time

    Job DescriptionJob Title: Medical Billing Specialist Company: Twin Cities Physicians Location: Golden Valley, MN Compensation: $23- $24 an hour Schedule: Full-Time (Mon. - Fri.) Twin Cities physicians is growing and is looking for a new addition to our fabulous billing department! As a Medical Billing Specialist, you will be responsible for generating and...

  • Regulatory Coordinator

    5 days ago

    Minneapolis, United States NESCO Inc Full time

    CORE RESPONSIBILITIES AND TASKS The Global Chemical Compliance Specialist is responsible for participating in governance processes that ensure compliance with chemical substance registration regulations across the globe. This position is part of a team that provides a full spectrum of chemical substance regulatory support to business groups and functional...

  • Regulatory Coordinator

    3 days ago

    Minneapolis, United States NESCO Inc Full time

    CORE RESPONSIBILITIES AND TASKS The Global Chemical Compliance Specialist is responsible for participating in governance processes that ensure compliance with chemical substance registration regulations across the globe. This position is part of a team that provides a full spectrum of chemical substance regulatory support to business groups and functional...

  • Medical Billing Specialist

    3 weeks ago

    Minneapolis, United States Home Health Care Full time

    Job Description Job Title: Medical Billing Specialist Company: Twin Cities Physicians Location: Golden Valley, MN Compensation: $23- $24 an hour Schedule: Full-Time (Mon. - Fri.) Twin Cities physicians is growing and is looking for a new addition to our fabulous billing department! As a Medical Billing Specialist, you will be responsible for...