88 Results for

Regulatory Affairs Specialist Jobs in Minnesota

Jobs

Business Professional - Regulatory Affairs Specialist Lancesoft

Maplewood, MN

$45
Quick Apply

As a Regulatory Affairs & Product Stewardship Associate within the Filtration & Separation business, you will support regulatory and product stewardship activities for a diverse portfolio of filtration, purification, bioprocessing, and life sciences products. You will also play a key role in maintaining accurate, complete, and reliable product composition information used to support regulatory compliance, product stewardship, customer requirements, and product lifecycle management.

15 days ago

Regulatory Affairs Specialist Lancesoft

Maplewood, MN

$50
Quick Apply

Onsite Job As a Regulatory Affairs & Product Stewardship Associate within the Filtration & Separation business, you will support regulatory and product stewardship activities for a diverse portfolio of filtration, purification, bioprocessing, and life sciences products. You will also play a key role in maintaining accurate, complete, and reliable product composition information used to support regulatory compliance, product stewardship, customer requirements, and product lifecycle management.

15 days ago

Sr. Regulatory Affairs Specialist - Recall and Post-Market Compliance (Hybird/Remote) Illumina Inc

Remote

$90,000–$135,000 / year

Key responsibilities include conducting timely assessments of potential adverse events and field actions to determine regulatory reportability, supporting MDR and recall decision-making, coordinating regulatory reporting activities, developing regulatory justifications and documentation, and ensuring compliance with applicable global regulations. The Senior Regulatory Affairs Specialist will be an instrumental member of the Regulatory Affairs team supporting on-market in vitro diagnostic (IVD) products in the United States and international markets.

11 days ago

Regulatory Affairs Specialist # 26-25704 US Tech Solutions, Inc.

Maplewood, MN

$45–$50 / hour
Quick Apply

You will also play a key role in maintaining accurate, complete, and reliable product composition information used to support regulatory compliance, product stewardship, customer requirements, and product lifecycle management. As a Regulatory Affairs & Product Stewardship Associate within the Filtration & Separation business, you will support regulatory and product stewardship activities for a diverse portfolio of filtration, purification, bioprocessing, and life sciences products.

15 days ago

Sr. Principal Regulatory Affairs Specialist - Bracco Medical Technologies Bracco SpA

Eden Prairie, MN

$159,000–$172,000 / year

This individual provides technical leadership and mentorship across Regulatory Affairs, drives regulatory excellence and continuous improvement, and leverages approved digital, automation, and generative AI tools to improve the quality, consistency, efficiency, and predictability of regulatory deliverables while maintaining appropriate human oversight and accountability for the final work product. The individual serves as a primary BMT representative in interactions with U.S. and international regulatory authorities and Notified Bodies, including independently developing FDA Pre-Submission strategies and meeting packages, leading regulatory authority meetings, presenting and defending BMT positions, and driving responses and follow-up actions.

17 days ago

Regulatory Affairs Specialist Varite, Inc

Maplewood, MN

$45–$50 / hour
Quick Apply

3-5 years of experience in Regulatory Affairs, Product Stewardship, Environmental Health & Safety, Product Compliance, Quality, or related technical functions (internships and co-op experience may be considered) Experience working with structured product, material, chemical, or composition data in enterprise systems. With 850+ global consultants, VARITE is committed to delivering excellence to its customers by leveraging its global experience and expertise in providing comprehensive scientific, engineering, technical, and non-technical staff augmentation and talent acquisition services.

2 days ago

Document Control Records Management - Regulatory Affairs Specialist - Senior LanceSoft Inc

Chaska, MN

$50–$53.95 / hour
Quick Apply

Responsibilities may include: - Administration of the company's complaint management program for compliance to corporate requirements - Planning and implementing pre-market registration, reporting and compliance activities in accordance with the development center business plans. Additionally, may provide assistance to technical departments, manufacturing business centers and suppliers in the creation and structuring of clinical data for pre-market notifications.

11 days ago

Regulatory Affairs Specialist Pride Global

Eagan, MN

Remote

$28–$37 / hour
Quick Apply

This applies to direct care staff (Examples: RN, LPN, Nurse Aides, Therapists) referred to Kentucky nursing facilities, assisted living communities, or long-term care facilities, in accordance with KRS 216.793. Only applicable for San Francisco Candidates : Under the San Francisco Lactation in the Workplace Ordinance, we will provide written notice of lactation accommodation rights, and this notice will automatically be given upon hiring, any inquiry of parental leave or lactation accommodation.

8 days ago

Regulatory Affairs Specialist Medtronic Plc

Mounds View, MN

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

3 days ago

Sr. Principal Regulatory Affairs Specialist - Bracco Medical Technologies Bracco

Eden Prairie, Minnesota

9 days ago

Regulatory affairs specialist Karwell Technologies

Minneapolis, MN

Quick Apply

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. 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.

30+ days ago

Senior Regulatory Affairs Specialist AtriCure

Minnetonka, Minnesota

The position will serve as regulatory representative on selected projects for new product development or line extension and will provide regulatory supervision on post-market product changes to maintain marketing approvals. Prepare US submissions as necessary including 510(k) regulatory applications, original PMAs & PMA supplements for device and manufacturing, drafting 510(k) letters to file to secure/maintain marketing approvals.

7 days ago

Regulatory Affairs Sr Specialist Zimmer Biomet Holdings Inc

Minnetonka, MN

$89,607–$134,411 / year

To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products.

28 days ago

Regulatory Affairs Specialist The Schwan Food Company

Marshall, MN

From kids devouring pizza after soccer practice, to students laughing over dumplings in a cafeteria, to families enjoying pie during the holidays, our team members play an important role in bringing those everyday moments to life. Our portfolio includes iconic pizzas, global flavors and timeless desserts from brands like Red Baron, bibigo, Tony's, Big Daddy's, Freschetta, Pagoda, Edwards and Mrs.

30+ days ago

Principal Regulatory Affairs Specialist - Bracco Medical Technologies Bracco SpA

Eden Prairie, MN

$131,000–$143,000 / year

Develop and execute regulatory plans for product submissions, including 510(k) Premarket Notifications, EU MDR Technical Documentation, Canadian Licensing Submissions, and select Japan/China submission content. If you are a seasoned regulatory affairs professional who enjoys shaping global regulatory strategy, partnering across technical teams, and supporting meaningful medical technology innovation, we invite you to apply.

30+ days ago

Regulatory affairs specialist Katalyst Healthcares & Life Sciences

Minneapolis, MN

Quick Apply

30+ days ago

Principal Regulatory Affairs Specialist Medtronic Plc

Mounds View, MN

This role is responsible for collaborating with cross-functional partners to develop, plan, and execute global regulatory strategies across early development, commercialization, lifecycle management, and business transition activities as well as supporting complex post-market release and sustaining change activities. If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

19 days ago

Senior Regulatory Affairs Specialist - Structural Heart (on-site) Abbott

Saint Paul, MN

$78,000–$156,000 / year

Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for Class III medical devices which may include software. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.

28 days ago

Principal Regulatory Affairs Specialist - Bracco Medical Technologies Bracco

Eden Prairie, Minnesota

30+ days ago

Regulatory Affair Specialist - Onsite Medtronic Plc

Minneapolis, MN

If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).

11 days ago

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Regulatory Affairs Specialist Jobs in Minnesota

Business Professional - Regulatory Affairs Specialist Lancesoft

Regulatory Affairs Specialist Lancesoft

Sr. Regulatory Affairs Specialist - Recall and Post-Market Compliance (Hybird/Remote) Illumina Inc

Regulatory Affairs Specialist # 26-25704 US Tech Solutions, Inc.

Sr. Principal Regulatory Affairs Specialist - Bracco Medical Technologies Bracco SpA

Regulatory Affairs Specialist Varite, Inc

Document Control Records Management - Regulatory Affairs Specialist - Senior LanceSoft Inc

Regulatory Affairs Specialist Pride Global

Regulatory Affairs Specialist Medtronic Plc

Sr. Principal Regulatory Affairs Specialist - Bracco Medical Technologies Bracco

Regulatory affairs specialist Karwell Technologies

Senior Regulatory Affairs Specialist AtriCure

Regulatory Affairs Sr Specialist Zimmer Biomet Holdings Inc

Regulatory Affairs Specialist The Schwan Food Company

Principal Regulatory Affairs Specialist - Bracco Medical Technologies Bracco SpA

Regulatory affairs specialist Katalyst Healthcares & Life Sciences

Principal Regulatory Affairs Specialist Medtronic Plc

Senior Regulatory Affairs Specialist - Structural Heart (on-site) Abbott

Principal Regulatory Affairs Specialist - Bracco Medical Technologies Bracco

Regulatory Affair Specialist - Onsite Medtronic Plc

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