Regulatory Affairs Specialist
Experis
Regulatory Affairs Specialist
Our client, a leader in the healthcare industry, is seeking a Regulatory Affairs Specialist to join their team. As a Regulatory Affairs Specialist, you will be part of the Regulatory Affairs Department supporting global post-market compliance activities. The ideal candidate will have attention to detail, strong analytical skills, and excellent collaboration abilities.
Location: Maple Grove, MN (Hybrid, 3 days onsite weekly)
What's the Job?
- Lead regulatory activities supporting product corrections, recalls, and field actions.
- Partner with internal global regulatory teams and external 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.
What's Needed?
- Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or a related scientific/technical discipline.
- 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 international medical device regulatory requirements.
What's in it for me?
- Opportunity to work in a dynamic and impactful healthcare environment.
- Engage in meaningful projects that contribute to global health and safety.
- Collaborate with a diverse and talented team of professionals.
- Develop your expertise in regulatory compliance and medical device regulations.
- Be part of a company committed to continuous improvement and innovation.
Upon completion of waiting period consultants are eligible for:
- Medical and Prescription Drug Plans
- Dental Plan
- Vision Plan
- Health Savings Account
- Health Flexible Spending Account
- Dependent Care Flexible Spending Account
- Supplemental Life Insurance
- Short Term and Long Term Disability Insurance
- Business Travel Insurance
- 401(k), Plus Match
- Weekly Pay
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Regulatory Affairs Specialist in Maple Grove, MN vacancy
- ...Regulatory Affairs SpecialistOur client, a leader in the healthcare industry, is seeking a Regulatory Affairs Specialist to join their team. As a Regulatory Affairs Specialist, you will be part of the Regulatory Affairs Department supporting global post-market compliance...SuggestedFlexible hours
Experis
Maple Grove, MN3 days ago - ...in medical technology.\This position will be instrumental in helping VDYNE achieve these ambitious goals. THE ROLE As a Regulatory Affairs Specialist at VDyne, you'll support regulatory operations and global clinical and commercial regulatory activities across an active...SuggestedWork at officeShift work
VDyne
Maple Grove, MN2 days ago - ...Possible 3 Month CTH Role: Regulatory affairs specialist Work location: Hybrid, Maple Grove, Minnesota (3 days onsite weekly) Background and Meet and Greet: MANDATORY Job Description: Position Summary Highly experienced Principal Regulatory...Suggested
Talent Software Services
Maple Grove, MN2 days ago $94k - $150k
Job TitleSenior Regulatory Affairs SpecialistJob DescriptionSenior Regulatory Affairs Specialist, UltrasoundThe Senior Regulatory Affairs Specialist for Ultrasound collaborates with regulatory teams and authorities to secure timely product clearances. Responsibilities...SuggestedFull timeWork at officeImmediate startWork visaRelocation package3 days per week- ...the right things and do things right The 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...SuggestedFull timeImmediate start
$59.9k
...not offer sponsorship or take over sponsorship of an employment VISA for this position at this time About the Role The Regulatory Affairs Specialist I supports product development, regulatory submissions, global registrations, and regulatory compliance activities throughout...Hourly payInternshipWork at officeLocal areaShift work3 days per week- ...a clinical-stage medical device company focused on transcatheter valve solutions for tricuspid regurgitation. We seek a Regulatory Affairs Specialist to support global regulatory activities across a growing portfolio and collaborate with Clinical, Quality, R&D, and Engineering...
- ...Senior Regulatory Affairs Specialist Work mode: Hybrid Onsite Location(s): Marlborough, MA, US, 01752 Additional Location(s): US-MA-Marlborough; US-MN-Maple Grove Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific...Work at officeLocal area3 days per week
Boston Scientific
Maple Grove, MN4 days ago - ...Principal Regulatory Affairs Specialist Work mode: Hybrid Onsite Location(s): Maple Grove, MN, US, 55311 Additional Location(s): US-MN-Maple Grove Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll...Work at officeLocal area3 days per week
Boston Scientific
Maple Grove, MN1 day ago - ...Senior Regulatory Affairs Specialist At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the...Work at officeLocal area3 days per week
- ...Regulatory Affairs Specialist We believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters – it's what fuels our motivation and contributes to our success. If you're ready to make a positive impact on the...WorldwideFlexible hours
Laborie Medical Technologies
Minnetonka, MN1 day ago - Tundra Technical Solutions in Maple Grove, MN is seeking a highly experienced Regulatory Affairs Specialist (Contract) to lead and support global post-market regulatory compliance for Interventional Cardiology and Vascular Therapies. This on-site role focuses on CAPA, PIRs...Contract work
$120k - $180k
...the LifeLOCATION: Onsite at a US-based Medtronic facility. Preference for the person to work EST hours. The Medtronic Global Regulatory Affairs team is looking for a highly motivated and skilled individual to join our Clinical Research, Medical Science, and Regulatory...Full timeH1bWork at officeLocal areaImmediate startFlexible hoursShift work- Laborie Medical Technologies is seeking a Regulatory Affairs Specialist for a hybrid role in Minnetonka, MN. You will support global product registrations and lifecycle maintenance for the US, Canada, Europe, and other regions. Responsibilities include preparing submissions...
- ...broad range of projects including, but not limited to, air and water permitting, compliance reporting, facility assessments, and regulatory negotiations. This position will have a very broad range of opportunities to work on Industrial compliance and permitting will receive...Full timeTemporary workCasual workWork at officeLocal areaMonday to FridayFlexible hoursNight shiftAfternoon shift
- ...AtriCure, Inc. in Minnesota seeks a Senior Regulatory Affairs Specialist to originate and maintain marketing privileges across US and international markets. You will submit 510(k), PMA supplements, and global filings, while guiding regulatory strategy on new products and...
AtriCure
Minnetonka, MN4 days ago $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...Contract workTemporary workFor contractorsWork experience placementFor subcontractorWork at officeLocal areaWorldwideAtriCure
Minnetonka, MN4 days ago$88k - $115k
...and USL Director of Compliance, the Paralegal / Corporate Compliance Specialist will support the legal operations, including general legal matters and IP related matters. This is a critical regulatory compliance role responsible for managing and maintaining all state Board...Contract workWork experience placementUpsher-Smith
Maple Grove, MN4 days ago- ...Pinnacle is seeking a motivated Compliance Specialist in Maple Grove, MN. This full-time role involves preparation of environmental permit applications, compliance reporting, and regulatory negotiations. You will collaborate on various projects to provide comprehensive...Full time
Pinnacle Engineering - MN, ND, NE, MT
Maple Grove, MN4 days ago - Boston Scientific is seeking a Product Complaint Analyst II to review patient complaints within the Urology portfolio and determine regulatory reportability. The role requires clinical data gathering from multiple sources and precise communication of investigations and...Work at officeRelocation package3 days per week
- ...Job Description Job Description A medical device client is hiring a permeant Sr. Regulatory Specialist, onsite in Maple Grove, MN. This person will assist with medical writing (including preparation and/or finalization of test reports), regulatory filings, review of...Work at office
Cypress HCM
Maple Grove, MN17 days ago $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 workWork experience placementWork at officeLocal areaWorldwide- Boston Scientific in Minnesota is seeking a Regulatory Affairs Specialist I to support product development, submissions, and global registrations across the medical device lifecycle. Working with cross-functional teams, you will help draft regulatory strategies, prepare...Work at office3 days per week
- AtriCure, Inc. seeks a Senior Regulatory Affairs Specialist to originate and maintain marketing privileges across US and international markets. This role will prepare submissions and support regulatory strategies for new product development and post-market changes. You...
- ...medical device industry, is seeking a Sr. Program Manager to join their team. As a Sr. Program Manager, you will be part of the Regulatory Program Management team supporting cross-functional initiatives. The ideal candidate will demonstrate strong leadership, strategic...Local area3 days per week
Experis
Maple Grove, MN5 days ago - Upsher-Smith is seeking a Paralegal / Corporate Compliance Specialist to support legal operations and manage state Boards of Pharmacy licenses in a hybrid Minnesota role. The position requires a Bachelor's in a business field, a Paralegal certificate, and at least 3 years...
$171k - $273k
Job TitleDirector of Regulatory Affairs - RespirTech (Plymouth, MN)Job DescriptionDirector of Regulatory Affairs - RespirTech (Plymouth, MN)The Director of Regulatory Affairs will lead the Philips RespirTech InCourage Vest Therapy Regulatory Affairs and Quality teams in...Full timeWork at officeImmediate startWork visaRelocation package3 days per week$85k - $135k
...Customs and Border Protection, the U.S. Department of Commerce (Census), Corporate Trade Compliance, internal legal counsel, and other regulatory agencies. Program Ownership: Develop, implement, and maintain trade compliance programs, policies, and procedures aligned...Local areaBunzl
Osseo, MN1 day ago- ...Socket.dev in Minnesota/Illinois seeks a Regulatory Product and Filing Specialist to manage filings for all lines of business, interact with state insurance departments, and ensure compliance across regulatory matters. The role covers rate and form filings, licensing...Work at office
Socket
Wayzata, MN5 days ago $35 - $37 per hour
...medical image annotation and data organization. Familiarity with cloud technologies (e.g., AWS), machine learning frameworks, and regulatory standards such as HIPAA and FDA 21 CFR Part 11. If you are interested in this role, then please click APPLY NOW. For other...Hourly payContract workTemporary workInternshipLocal areaAkkodis
Maple Grove, MN5 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Affairs Specialist. Be the first to apply!
Related searches
- regulatory affairs specialist Maple Grove, MN
- medicare compliance specialist Maple Grove, MN
- regulatory compliance analyst Maple Grove, MN
- compliance specialist Maple Grove, MN
- aml compliance analyst Maple Grove, MN
- regulatory officer Maple Grove, MN
- healthcare compliance officer Maple Grove, MN
- regulatory analyst Maple Grove, MN
- regulatory specialist Maple Grove, MN
- compliance associate Maple Grove, MN