Regulatory affairs specialist

Katalyst Healthcares and Life Sciences

Minneapolis, MN

Job Description:

Highly experienced Principal Regulatory Affairs Specialist to lead and support global post-market regulatory compliance activities within the Interventional Cardiology and Vascular Therapies Division. This role is responsible for ensuring compliance with global regulatory requirements related to product incident reporting, corrective and preventive actions (CAPA), recalls, field actions, audits, and post-market surveillance activities.
The ideal candidate will possess deep knowledge of U.S. and international medical device regulations, strong analytical capabilities, and the ability to collaborate effectively across cross-functional teams to drive compliance and continuous improvement initiatives.

Responsibilities:

Lead regulatory activities supporting product corrections, recalls, and field actions.
Partner with internal global regulatory teams and external regulatory authorities regarding recall-related communications and submissions.
Manage Product Incident Reports (PIRs), including investigation, risk assessment, documentation, and regulatory reporting.
Drive development, implementation, and monitoring of CAPAs to address nonconformances and improve regulatory processes.
Support internal and external audits, inspections, and compliance assessments.
Ensure compliance with FDA regulations, EU MDR requirements, and other international regulatory frameworks.
Monitor evolving global regulatory requirements and communicate regulatory updates to stakeholders.
Provide regulatory guidance for post-market surveillance and quality-related activities.
Develop and deliver regulatory compliance training to internal teams.
Collaborate with Quality, Clinical, Engineering, Manufacturing, and Commercial teams to ensure regulatory compliance throughout the product lifecycle.

Requirements:

Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or a related scientific/technical discipline, along with 12+ years of relevant industry experience.
Minimum 5 years of experience in Regulatory Affairs and/or Quality within the medical device, healthcare, or life sciences industry.
Minimum 2 years of direct Regulatory Affairs experience.
Strong knowledge of U.S. FDA regulations and medical device regulatory requirements.

Experience managing:

Product Incident Reports (PIRs).
Corrective and Preventive Actions (CAPAs).
Product recalls and field corrective actions.
udit and inspection support activities.
Experience using regulatory systems, databases, and documentation tools.
Strong written and verbal communication skills.

Apply

Vacancy posted 4 days ago

Similar jobs that could be interesting for youBased on the Regulatory affairs specialist in Minneapolis, MN vacancy

Regulatory Affairs Specialist
$107.2k - $160.8k
...Regulatory Affairs Specialist Location: Minneapolis, MN, US Job Family: Country/Region: United States he Regulatory Affairs Specialist is responsible for day-to-day regulatory affairs tasks required to maintain compliance with Coloplast...
Suggested
Work at office
Local area
Immediate start
Flexible hours
Coloplast
Minneapolis, MN
1 day ago
Regulatory affairs specialist
...Principal Regulatory Affairs Specialist Highly experienced Principal Regulatory Affairs Specialist to lead and support global post-market regulatory compliance activities within the Interventional Cardiology and Vascular Therapies Division. This role is responsible...
Suggested
Katalyst HealthCares & Life Sciences
Minneapolis, MN
22 hours ago
Regulatory Affairs Specialist II
$70k - $110k
...Shift Type Job Title Regulatory Affairs Specialist II Education Bachelor's Degree Location Minneapolis, MN 55401 US (Primary) Career Level Experienced (Non-Manager) Category Regulatory and Compliance Date Needed By Job Type Full-time...
Suggested
Full time
Work at office
Shift work
Stereotaxis
Minneapolis, MN
2 days ago
Senior Regulatory Affairs Specialist
...Job TitleThe primary purpose of this job is to strategically plan, execute and provide oversight to regulatory activities necessary to obtain and maintain regulatory approvals within the United States and International markets and ensure compliance with relevant FDA,...
Suggested
Immediate start
Integer Holdings Corporation
Minneapolis, MN
4 days ago
Global Regulatory Affairs Specialist - Medical Devices
...Scanlan International, Inc. is a medical device company seeking a Regulatory Affairs Specialist to maintain market authorizations and oversee regulatory documentation for worldwide markets. The role is based at the headquarters south of downtown St. Paul with an on-site...
Suggested
Worldwide
Monday to Friday
Scanlan International, Inc.
Minneapolis, MN
1 day ago
Regulatory Affairs Specialist
...wound healing technologies, and advanced medical devices for use in the healthcare industry. We are currently seeking a Regulatory Affairs Specialist that will be able to ensure compliance with regulations. Responsibilities Include Communicate with regulatory agencies regarding...
Full time
Work at office
Hemostasis Corp
Saint Paul, MN
2 days ago
Regulatory Affairs Specialist
$74.4k - $111.6k
...functional collaboration as we work together to engineer the extraordinary.?This position will be based in Mounds View, MN.The Regulatory Affairs Specialist assists in the development of strategies for worldwide product registration with global regulatory agencies to introduce...
H1b
Local area
Immediate start
Remote work
Worldwide
Flexible hours
Medtronic plc
Saint Paul, MN
22 hours ago
Regulatory Affairs Specialist
...Regulatory Affairs SpecialistThe Regulatory Affairs Specialist will assist in maintaining market authorizations for Scanlan products, including design files, technical documentation, product registrations and listings. They will also assist with post-market surveillance...
Work experience placement
Work at office
Worldwide
Scanlan International, Inc.
Saint Paul, MN
3 days ago
Regulatory Affairs Specialist II
$61.3k - $122.7k
...and management solutions for the treatment of structural heart disease. The Opportunity We are recruiting for a Regulatory Affairs Specialist to join our team on-site in New Brighton, MN. This new team member will be overseeing our innovating Transcatheter...
Shift work
Abbott
New Brighton, MN
2 days ago
Compliance Specialist
$65k - $85k
...structural glass facades in North America. As our Compliance Specialist, you will play a critical role in supporting the continued growth... ...and documentation to support audits, legal inquiries, or regulatory reviews. Coordinate with estimating, safety, legal, risk, and...
Full time
For contractors
Work experience placement
For subcontractor
Work at office
Local area
Flexible hours
Enclos
Minneapolis, MN
1 day ago
Compliance Analyst
...understand requirements of pertinent federal, state and local regulatory schemes in reference to all business units within the organization... ...a fast?moving environmentBackground in compliance, regulatory affairs, or similarExperience with large, complex organizations,...
Local area
Omni Inclusive
Minneapolis, MN
22 hours ago
Compliance Analyst
...need to be able to get up to speed fairly quickly on unfamiliar territory).Job DutiesAssist CCO with review and implementation of regulatory initiatives, review and interpret rules and guidance, documentation of policies and proceduresAssist with daily, weekly, monthly,...
Work at office
NOVON Consulting Corp.
Minneapolis, MN
22 hours ago
Compliance Officer
...The selectee serves as a Compliance Officer providing regulatory oversight on the possession, use and transfer of biological select agents and toxins. This position requires a thorough understanding of how to evaluate that proper procedures are in place at regulated entities...
Local area
U.S. Department of Agriculture
Minneapolis, MN
1 day ago
Compliance Officer
...Compliance OfficerThe selectee serves as a Compliance Officer providing regulatory oversight on the possession, use and transfer of biological select agents and toxins. This position requires a thorough understanding of how to evaluate that proper procedures are in place...
US Government Jobs
Minneapolis, MN
3 days ago
HR Data & Compliance Analyst
$75k - $80k
...Position Summary:The HR Data & Compliance Analyst is responsible for managing and analyzing HR data, ensuring compliance with legal and regulatory requirements, and optimizing HRIS reporting processes. This role involves generating reports, maintaining data accuracy, and...
Temporary work
Work experience placement
Local area
Remote work
Wurth Industry North America
Minneapolis, MN
3 days ago
Principal Regulatory Affairs Specialist
...supported in progressing – whatever your ambitions. About the role:We are seeking a highly skilled and experienced Principal Regulatory Affairs Specialist to join our Interventional Oncology and Embolization division. In this role, you will play a pivotal role in supporting...
Hourly pay
Work at office
Local area
Shift work
3 days per week
Boston Scientific
Osseo, MN
3 days ago
Senior Regulatory Affairs Specialist
$89.2k
...quality of patient care with innovative Urology solutions. We are looking to hire an enthusiastic individual for a Senior Regulatory Affairs Specialist position (hybrid work mode) supporting our rapidly growing active implantable device portfolio. This role will be...
Hourly pay
Work at office
Local area
Relocation
Shift work
3 days per week
Boston Scientific
Arden Hills, MN
2 days ago
Information Technology Risk & Compliance Analyst
$90k - $100k
ECMC Group is a nonprofit corporation focused on helping students succeed. Headquartered in Minneapolis, ECMC Group and its family of companies provide financial tools and services, as well as funding for innovative programs to help students achieve their academic and ...
Full time
Work at office
Flexible hours
ECMC Group
Minneapolis, MN
2 days ago
Senior Regulatory Affairs Specialist
$106k - $130k
...enriching and equitable opportunities for each person to contribute professionally and personally. POSITION SUMMARY: The Senior Regulatory Affairs Specialist originates appropriate documents to obtain and maintain marketing privileges consistent with applicable government...
Temporary work
Work experience placement
Work at office
Local area
Worldwide
AtriCure
Minnetonka, MN
1 day ago
Compliance Specialist Senior Wealth Management
$85k - $145k
...COMPLIANCE SPECIALIST SENIOR WEALTH MANAGEMENT WHAT IS THE OPPORTUNITY? The Compliance... ...effective compliance program to ensure regulatory compliance for Bank Wealth Management products... ...exam management and other regulatory affairs. For Banking Compliance related roles...
Remote work
City National Bank
Minneapolis, MN
3 days ago
Affordable Housing Compliance Specialist
$70k - $80k
...questions (****@*****.***). JOB SUMMARY The Compliance Specialist is responsible for auditing and monitoring the recertification... ...and leasing processes of site files to ensure compliance with regulatory requirements, including Project-Based Section 8. This role coordinates...
Contract work
Temporary work
Work at office
Local area
Bigos Management
Golden Valley, MN
4 days ago
AML Compliance Analyst
$1,800 - $2,300 per month
...This role provides second‑line oversight and day‑to‑day advisory support across a wide range of business activities by translating regulatory requirements into practical guidance, executing operational compliance reviews, and producing governance‑ready documentation and...
Contract work
Sezzle
Minneapolis, MN
2 days ago
Principal Regulatory Affairs Specialist
$80.9k - $127.05k
...MA-Mansfield-West Building Full time 20184380 What Regulatory Affairs contributes to Cardinal Health Regulatory provides regulatory... .... Job Summary The Principal Regulatory Affairs Specialist will support the Medical Solutions Regulatory affairs team....
Full time
Temporary work
Work experience placement
Local area
Immediate start
Remote work
Flexible hours
Cardinal Health
Saint Paul, MN
4 days ago
Credentialing Specialist
...One Federal Solution is seeking Credentialing Specialists to support a large federal identity credentialing program. The Credentialing Specialist will perform credential enrollment, issuance, activation, inventory management, and customer support activities while ensuring...
Permanent employment
For contractors
Work experience placement
Work at office
One Federal Solution
Minneapolis, MN
4 days ago
Credentialing Specialists
...Credentialing Specialists Credentialing Specialists will provide credentialing service and support to operate IRS credentialing sites utilizing the GSA scheduling tool to manage credentialing appointments, run reports through the USAccess system, and use credentialing...
Temporary work
For contractors
Local area
Shift work
Night shift
Weekend work
Armada
Minneapolis, MN
2 days ago
Regulatory & Clinical Specialist
$85k - $95k
...Regulatory And Clinical SpecialistAs a global medtech company, we are driven by our Vision... ...course of lives.The Regulatory and Clinical Specialist will support the clinical evaluation... ...medical writing and medical device regulatory affairs or a Ph.D. with at least 3 years of...
Remote work
Worldwide
LivaNova
Minneapolis, MN
22 hours ago
Senior Data Analyst
$100k
Celebrated as one of Minnesota's Top Workplaces! Knutson Construction is accepting applications for a Senior Data Analyst to join our team in Minneapolis, MN. "Together We Make Dreams Real" - that is our purpose as a company and we exist to work in concert with...
Full time
Work at office
Local area
Flexible hours
Knutson Construction
Minneapolis, MN
a month ago
Salesforce Data & Reporting Analyst/Senior Analyst
Job Description What is the opportunity? Working in a fast-paced, agile environment, the Salesforce Data & Reporting Analyst/Senior Analyst will be responsible for identifying and collecting data sources, analyzing and extracting key data and information, evaluating...
Full time
Work at office
Flexible hours
Royal Bank of Canada
Minneapolis, MN
more than 2 months ago
Data Analyst
Data Analyst All IT Solutions United States · Minneapolis, Minnesota Workplace Type — Remote Employment Type — Contract We are currently seeking a qualified Data Analyst to support this engagement. Please review the complete requirements, work location, employment...
Contract work
Temporary work
Local area
Remote work
All IT Solutions
Minneapolis, MN
5 days ago
Senior Financial Reporting Analyst
$106.5k
Want to leave public accounting without leaving behind the challenge? We’re partnering with a multi-billion-dollar organization that recently transitioned to private equity ownership- and its finance organization is evolving right along with it. This Senior Financial Analyst...
Relocation
Ambrion
Minneapolis, MN
4 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Regulatory affairs specialist. Be the first to apply!