Top 119 Regulatory affairs lead Jobs in Minneapolis Mn

Director of Regulatory Affairs - Remote
UnitedHealth Group —Eden Prairie, MN
- $134,600 - $230,800 a year
- Full-time
- Hybrid work
- Pass drug screening
- Office
- Continuous improvement
Regulatory Affairs Intelligence Specialist
Abbott Laboratories —Saint Paul, MN
- $50,700 - $101,300 a year
- Full-time
- Microsoft Outlook
- Mid-level
- Office
- Health insurance
- Tuition reimbursement
2d
Principal Regulatory Affairs Specialist - Global Harmonization Policy & Key Initiatives
Medtronic —Fridley, MN
- $120,000 - $180,000 a year
- Full-time
- 5 years
- Office
- Bachelor's degree
- Health savings account
- Employee stock purchase plan
5d
Process Optimization & Integration Lead
U.S. Bank National Association —Minneapolis, MN
- $214,795 - $252,700 a year
- Full-time
- Bachelor's degree
- US work authorization
- Fair chance
- Paid holidays
- Disability insurance
Director of Regulatory Affairs - RespirTech (Plymouth, MN)
Philips —Plymouth, MN
- $171,000 - $273,000 a year
- Full-time
- Office
- 3 years
- Travel
- Health savings account
- Employee stock purchase plan
Principal Regulatory Affairs Specialist - Advertising & Promotion
Boston Scientific —Arden Hills, MN
- $102,100 - $194,000 a year
- Hybrid work
- Microsoft Excel
- Marketing
- 5 years
Lead Compliance Consultant - Responsible AI & Privacy
Target —Minneapolis, MN
- $95,000 - $171,000 a year
- Full-time
- 6 years
- Computer Science
- Office
- Paid holidays
- Disability insurance
Regulatory affairs specialist
Katalyst Healthcares & Life Sciences —Minneapolis, MN
- Contract
- Hybrid work
- Analysis skills
- Training & development
- Senior level
Quick Apply
Manager, Regulatory & Payer Operations Support
Coloplast —Minneapolis, MN
- $95,898 - $143,847 a year
- Hybrid work
- Bachelor's degree
- Mentoring
- Business Administration
- Paid parental leave
- Dental insurance
REGULATORY AFFAIRS SPECIALIST
Capgemini —Maple Grove, MN
- $39.30 - $61.40 an hour
- Contract
- Analysis skills
- Fair chance
- Training & development
- Health insurance
- Dental insurance
Staff Global Regulatory GPO
Beckman Coulter Diagnostics —Chaska, MN
- $140,000 - $170,000 a year
- Full-time
- Doctoral degree
- Writing skills
- Master's degree
- Health insurance
- Dental insurance
Chief Product Officer
Grüns —Minneapolis, MN
- $350,000 a year
- Remote
- 11+ years
- Senior level
- Leadership
- Paid time off
Quick Apply
Food Safety & Quality Assurance Manager (S1268)
Wellness Pet Company —South Saint Paul, MN
- $110,000 - $140,000 a year
- Full-time
- 5 years
- Organizational skills
- Senior level
- Paid parental leave
- AD&D insurance
Quick Apply
Customer and Regulatory Specialist
Hawkins Inc —Roseville, MN
- $70,000 - $80,000 a year
- Microsoft Excel
- Microsoft Outlook
- Office
- Employee stock purchase plan
- Paid holidays
Quick Apply
Regulatory UDI & Data Syndication Lead
Horizontal Talent —Eagan, MN
- 5 years
- Master's degree
- SQL
6d
Associate Director Regulatory Affairs
EPM Scientific —Minneapolis, MN
- 3 years
- Mentoring
- Organizational skills
Quick Apply
Senior Design Assurance Engineer
Manpower Engineering —Fridley, MN
- $100,000 - $130,000 a year
- Full-time
- 5 years
- Engineering
- Office
- Health savings account
- Health insurance
Quick Apply
VP Global Quality and Regulatory
Trelleborg Medical Solutions —Plymouth, MN
- $220,000 a year
- Hybrid work
- Management
- 11+ years
- Office
- Disability insurance
- Health insurance
Quick Apply
Quality and Regulatory Manager
Nonin Medical —Minneapolis, MN
- Background check
- 3 years
- Experience equivalent to degree accepted
- Health insurance
- Dental insurance
Quick Apply
Clinical & Regulatory Affairs Specialist
Meditrial Europe Ltd. —Minneapolis, MN
- Full-time
- Office
- Master's degree
- Bachelor's degree

I want to receive the latest job alert for regulatory affairs lead in minneapolis mn

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

regulatory affairs lead jobs near minneapolis mn

Regulatory Affairs Specialist jobs in Minneapolis, MN

Director Of Regulatory Affairs jobs in Minneapolis, MN

Regulatory Affairs Specialist jobs in Arden Hills, MN

Regulatory Affairs Specialist jobs in Maple Grove, MN

Regulatory Affairs Specialist jobs in Fridley, MN

Quality Manager jobs in Minneapolis, MN

Director Of Regulatory Affairs jobs in Eden Prairie, MN

Compliance Consultant jobs in Minneapolis, MN

Operations Manager jobs in Minneapolis, MN

Peer Support Specialist jobs in Staten Island, NY

Regulatory Affairs Specialist jobs in Waukesha, WI

Veteran Affairs jobs in Huntsville, AL

Regulatory Affairs Specialist jobs in Durham, NC

Regulatory Affairs Specialist jobs in Redmond, WA

Clinical Documentation Specialist jobs in Richmond, VA

Benefits Specialist jobs in Columbia, SC

Regulatory Affairs Specialist jobs in Tennessee

Chief Product Officer jobs in Rancho Cucamonga, CA

Chief Product Officer jobs in Atlanta, GA

Chief Nursing Officer jobs in San Diego, CA

Director of Regulatory Affairs - Remote

UnitedHealth Group -
Eden Prairie, MN

Apply Now

Job Details

Full-time
$134,600 - $230,800 a year

Qualifications

FDA submissions
ISO standards
Project management lifecycle
Team management
Task prioritization
Regulatory/legal compliance standards in production
Regulatory submission editing and review
Biomedical regulatory compliance
Managing projects
Quality audits
Cross-functional collaboration
Cross-functional communication

Full Job Description

UnitedHealth Group is a health care and well-being company that's dedicated to improving the health outcomes of millions around the world. We are comprised of two distinct and complementary businesses, UnitedHealthcare and Optum, working to build a better health system for all. Here, your contributions matter as they will help transform health care for years to come. Make an impact with a team that shares your passion for helping others. Join us to start Caring. Connecting. Growing together.

The Director of Regulatory Affairs will be a member of the Legal Team responsible for providing the enterprise with strategic counsel and support on regulatory and quality matters related to medical devices, including software and algorithms, and other digital health technologies. As a subject matter expert and leader, the Director of Regulatory Affairs will play a key role in developing and optimizing our regulatory affairs team, programs, and services. The Director of Regulatory Affairs will be responsible for maintaining and continuously improving enterprise regulatory affairs policies and procedures. Working closely with their team, legal and compliance colleagues, and business stakeholders, the Director of Regulatory Affairs will lead or support a wide range of regulatory activities, including regulatory assessments for new product/therapies and changes to existing products and the development and the execution of regulatory plans/strategies as required.

You'll enjoy the flexibility to work remotely * from anywhere within the U.S. as you take on some tough challenges. For all hires in the Minneapolis or Washington, D.C. area, you will be required to work in the office a minimum of four days per week.

Primary Responsibilities:

Lead and draft, review, and provide guidance on regulatory product assessments and other deliverables
Prepare regulatory plans/strategies and provide ongoing support as needed for various regulatory, quality, and compliance activities
Provide expert and practical regulatory advice and support on regulatory and quality requirements throughout a project or product lifecycle
Effectively communicate complex regulatory topics to a broad audience in our enterprise and collaborate across the enterprise to successfully strategize and achieve regulatory and quality objectives
Review and provide guidance on labeling including promotional labeling and advertisements (promotional communications)
Collecting, analyzing, and disseminating regulatory intelligence on new and changing requirements, policies, and guidelines
Support regulatory compliance activities, including manufacturing site registration, audits, inspections, post-market vigilance reporting, and product recalls
Prepare or support regulatory submissions and filings as needed
Develop and present educational and training material covering medical device and digital health regulatory affairs topics
Manage and participate in trade associations covering medical device topics and issues

You'll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in.

Required Qualifications:

10+ years of experience in medical device regulatory affairs or related field
Proven experience in preparing and submitting regulatory documentation including filings to the FDA, EU MDR, and/or other global regulatory agencies
Experience with completing or supporting regulatory compliance activities like site registrations, audits, post-market vigilance reporting, and product recalls
Demonstrated familiarity using and/or managing electronic quality management systems
Proven expertise and working knowledge of applicable regulations, standards and guidance for medical devices (FDA, QSMR, SaMD, ISO 13485, ISO 14971, IEC 62304, and other global regulatory requirements and quality standards)
Proven ability to learn and adapt to provide strategic regulatory advice in an evolving industry
Proven excellent written and oral communication, interpersonal, and problem-solving skills to effectively interact with others, including cross-functional teams and regulatory agencies, and address regulatory matters
Demonstrated ability to successfully manage multiple regulatory projects, priorities, and people, if relevant

Preferred Qualifications:

J.D., RAC Certification, ISO 13485 or other medical device auditor certification
Direct experience with Software as a Medical Devices (SaMD), other Digital Health products, and accessories
Direct experience with AI/ML-enabled medical devices or digital health technology

All employees working remotely will be required to adhere to UnitedHealth Group's Telecommuter Policy.

Pay is based on several factors including but not limited to local labor markets, education, work experience, certifications, etc. In addition to your salary, we offer benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). No matter where or when you begin a career with us, you'll find a far-reaching choice of benefits and incentives. The salary for this role will range from $134,600 to $230,800 annually based on full-time employment. We comply with all minimum wage laws as applicable.

Application Deadline: This will be posted for a minimum of 2 business days or until a sufficient candidate pool has been collected. Job posting may come down early due to volume of applicants.

At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone-of every race, gender, sexuality, age, location and income-deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes - an enterprise priority reflected in our mission.

UnitedHealth Group is an Equal Employment Opportunity employer under applicable law and qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

UnitedHealth Group is a drug - free workplace. Candidates are required to pass a drug test before beginning employment.

Apply Now

Refine Your Search

regulatory affairs lead jobs in minneapolis mn

Director of Regulatory Affairs - Remote

Regulatory Affairs Intelligence Specialist

Principal Regulatory Affairs Specialist - Global Harmonization Policy & Key Initiatives

Process Optimization & Integration Lead

Director of Regulatory Affairs - RespirTech (Plymouth, MN)

Principal Regulatory Affairs Specialist - Advertising & Promotion

Lead Compliance Consultant - Responsible AI & Privacy

Regulatory affairs specialist

Manager, Regulatory & Payer Operations Support

REGULATORY AFFAIRS SPECIALIST

Staff Global Regulatory GPO

Chief Product Officer

Food Safety & Quality Assurance Manager (S1268)

Customer and Regulatory Specialist

Regulatory UDI & Data Syndication Lead

Associate Director Regulatory Affairs

Senior Design Assurance Engineer

VP Global Quality and Regulatory

Quality and Regulatory Manager

Clinical & Regulatory Affairs Specialist

I want to receive the latest job alert for regulatory affairs lead in minneapolis mn

Related Searches

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected