Top 4583 Regulatory Jobs in Minneapolis Mn

Regulatory Affairs Specialist I
Boston Scientific —Maple Grove, MN
- $59,900 - $113,800 a year
- Hybrid work
- Office
- Master's degree
- Bachelor's degree
1d
Regulatory Affairs Specialist
Medtronic —Mounds View, MN
- $74,400 - $111,600 a year
- Full-time
- Mid-level
- Office
- Bachelor's degree
- Health savings account
- Employee stock purchase plan
11d
Online Sweepstakes Reviewer (Remote) - Paid Contract Position
Signup Expert —Saint Paul, MN
- Contract
- Remote
- Research
- Communication skills
- Entry level
Quick Apply
PNI Post Pay Regulatory Referral Compliance
Optum —Plymouth, MN
- $60,200 - $107,400 a year
- Full-time
- Remote
- Microsoft Outlook
- Pass drug screening
- Mid-level
9d
REGULATORY AFFAIRS SPECIALIST
Capgemini —Maple Grove, MN
- $39.30 - $61.40 an hour
- Contract
- Analysis skills
- Fair chance
- Training & development
- Health insurance
- Dental insurance
Regulatory Affairs Specialist
Rangam Consultants Inc. —Saint Paul, MN
- $32 - $40 an hour
- Contract
- Mid-level
- Office
- Bachelor's degree
Quick Apply
8d
Regulatory Affairs Specialist II
Stereotaxis —Minneapolis, MN
- Full-time
- Bachelor of Science
- Mid-level
- Office
Regulatory Affairs Specialist I
Laborie Medical Technologies Corp —Minnetonka, MN
- Full-time
- Hybrid work
- Engineering
- Mid-level
- Office
- Health savings account
- Health insurance
Quick Apply
10d
Regulatory affairs specialist
Katalyst Healthcares & Life Sciences —Minneapolis, MN
- Contract
- Hybrid work
- Analysis skills
- Training & development
- Senior level
Quick Apply
Regulatory Content Project Manager
Resideo —Golden Valley, MN
- $108,340 - $230,575 a year
- Full-time
- Hybrid work
- Residential
- Product management
- Organizational skills
Regulatory Affairs Specialist II – Electrophysiology (on-site)
Abbott Laboratories —Plymouth, MN
- $61,300 - $122,700 a year
- Full-time
- Microsoft Excel
- Mid-level
- Master's degree
- Health insurance
- Tuition reimbursement
Case Specialist / Regulatory Project Manager
Xcel Energy —Minneapolis, MN
- $80,000 - $100,000 a year
- Overtime
- Word processing
- Bachelor of Science
- Bachelor's degree
- Health savings account
- Paid holidays
10d
Regulatory Affairs Specialist
AtriCure —Minnetonka, MN
- $85,000 - $104,000 a year
- Hybrid work
- Background check
- Pass drug screening
- Mid-level
- Paid parental leave
- Health insurance
7d
International Regulatory Affairs Specialist
MGK —Brooklyn Park, MN
- $90,000 - $100,000 a year
- Full-time
- Spanish
- Microsoft Outlook
- 5 years
- Health insurance
- Paid time off
Specialist, Risk and Compliance Services (Onboarding)
Deloitte —Minneapolis, MN
- $63,000 - $116,000 a year
- Full-time
- Microsoft Word
- Mid-level
- 3 years
MRI Technologist - Up to $15,000 Sign-On Bonus
Fairview Health Services —Minneapolis, MN
- $41.82 - $56.63 an hour
- Weekends as needed
- BLS Certification
- Mid-level
- 1 year
Senior Packaging Engineer
Lifecore Biomedical Inc —Chaska, MN
- $95,000 - $110,000 a year
- Full-time
- 5 years
- Bachelor of Science
- Engineering
- Health savings account
- Paid holidays
MRI Technologist - Up to $9,000 Sign-On Bonus
Fairview Health Services —Minneapolis, MN
- $39.42 - $53.38 an hour
- Weekends as needed
- BLS Certification
- Mid-level
- 1 year
MRI Technologist - Up to $13,500 Sign-On Bonus
Fairview Health Services —Edina, MN
- $38.51 - $54.36 an hour
- BLS Certification
- Mid-level
- Clinic
CT Technologist - Casual
Fairview Health Services —Blaine, MN
- $36.64 - $51.73 an hour
- Monday to Friday
- BLS Certification
- Clinic
- 1 year

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Regulatory Affairs Specialist I

Boston Scientific -
Maple Grove, MN

Apply Now

Job Details

$59,900 - $113,800 a year
1 day ago

Qualifications

Genomics
Bachelor's degree
Biomedical regulatory compliance

Full Job Description

Additional Location(s): N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

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 latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

We will consider qualified applicants of all ages who are starting (or restarting) their careers

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model, requiring employees to be in our local office at least three days per week.

Boston Scientific will 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 the medical device lifecycle. Working under the guidance of experienced regulatory professionals, this role partners with cross-functional teams to assist with regulatory strategy, prepare and maintain submission documentation, assess product and manufacturing changes, support continued market access, and promote quality and continuous improvement.

Your Responsibilities Will Include

Assist in developing and maintaining productive relationships with regulatory agency and notified body reviewers through clear oral and written communications regarding regulatory pathways, testing requirements, submission questions, clarifications, and follow-up activities.

Assist in drafting and implementing regulatory strategies for new and modified medical devices to include Mechanical Circulatory Support systems.

Support cross-functional development teams by providing regulatory feedback and guidance throughout the product development cycle.

Coordinate and compile team inputs and supporting documentation for U.S., EU, and other global regulatory submissions.

Assist with preparation, submission, and maintenance of regulatory applications and internal regulatory file documentation.

Support international regulatory partners in obtaining and maintaining product registrations and approvals.

Review device labeling and advertising materials for consistency with approved submissions and applicable regulatory requirements; analyze and recommend appropriate changes.

Review product, design, manufacturing, supplier, and process changes to assess regulatory impact and support compliance with applicable requirements.

Prepare and maintain change impact assessments and other regulatory records supporting continued compliance with regulatory agency approvals.

Understand and support product lifecycle processes, including sustaining and regulatory approval maintenance activities.

Demonstrate commitment to patient safety, product quality, the Quality Policy, and applicable quality system regulations through daily work practices.

Required Qualifications

Bachelor's degree in Genetics and Genomics.

Must be eligible to work in the United States without company sponsorship, now or in the future, for employment-based work authorization.

At least three months of experience in Regulatory Affairs.

Prior internship experience with Boston Scientific.

Familiarity with U.S. FDA, EU medical device, and international regulatory requirements.

Experience supporting technical writing, document review, change assessment, or product development activities.

Preferred Qualifications

Master's degree in Biotechnology.

Experience or coursework related to medical devices, biotechnology, engineering, quality, clinical research, or regulatory affairs.

Strong written and verbal communication skills, including the ability to analyze, organize, and clearly present technical information.

Ability to collaborate effectively on cross-functional teams and manage multiple assignments and priorities.

Attention to detail and commitment to maintaining accurate, complete regulatory documentation.

Requisition ID: 633261

Minimum Salary: $ 59900

Maximum Salary: $ 113800

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

Apply Now

Refine Your Search

regulatory jobs in minneapolis mn

Regulatory Affairs Specialist I

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