Senior Regulatory Affairs Strategist — FDA 510(k) Expert
Elucent Medical Inc.
Elucent Medical Inc. is seeking a Principal Regulatory Affairs Specialist to lead regulatory strategies and submissions for medical devices. This role focuses on FDA 510(k) pathways, ensuring compliance throughout the product lifecycle. With a minimum of 7 years of experience in Regulatory Affairs, the ideal candidate will have proven hands-on expertise in preparing and supporting FDA submissions, strong regulatory judgment, and technical writing skills necessary for successful interactions with regulatory bodies. #J-18808-Ljbffr Elucent Medical Inc.
$120k - $135k
...Job Title Principal Regulatory Affairs Specialist Department Regulatory Reports to Director of Regulatory... ...advanced, specialized knowledge of U.S. FDA medical device regulations, FDA guidance... ...experience preparing and supporting FDA 510(k)s, pre‑submissions/Q‑submissions,...SuggestedFull timeTemporary workLocal areaMonday to FridayFlexible hours$66.57k - $91.52k
Sedgwick is looking for a Litigation Specialist in Eden Prairie, Minnesota, to address complex cases involving serious injuries and legal disputes. The role requires the formulation of strategies for resolution and effective communication with legal parties involved. The...Senior- A leading health care company in Eden Prairie, MN is seeking a Mergers & Acquisitions Senior Associate. This role involves evaluating M&A targets and building financial models to support the company's strategic initiatives. Candidates should have a Bachelor's degree in...Senior
- American Family Insurance Agency Staff is seeking a Senior Product Analyst based in Minnesota. The role involves leading the development of new Homeowners insurance products, focusing on compliance, profitability, and customer experience. You will perform complex analytical...SeniorWork at office
- ...Crains Cleveland is looking for a Senior Medical Coder to enhance health outcomes by ensuring precise coding for billing purposes. This remote opportunity offers a chance to connect with patients while managing coding accuracy. Applicants must possess a High School Diploma...SeniorRemote workMonday to Friday
$24 - $43 per hour
...Stryker Corporation is seeking a Senior Medical Coder to ensure accurate medical coding for reimbursement and support functions within charge review and claim edits. This role is pivotal in maintaining coding accuracy and supporting the revenue cycle. The ideal candidate...SeniorHourly payRemote work$24 - $43 per hour
...The Texas Health Institute is seeking a Senior Medical Coder to work remotely. This role involves reviewing and assigning CPT and E/M codes accurately to ensure maximum reimbursement for various specialties. Candidates should have 3+ years of coding experience, advanced...SeniorHourly payFull timeRemote workFlexible hours- Elijahhouseliving is seeking an individual to oversee the operations of the hearing center in Eden Prairie, Minnesota. The role involves managing employees and providing excellent service to members. In addition to the operational responsibilities, the position includes...Senior
- Elucent Medical, Inc. is hiring a Principal Regulatory Affairs Specialist in Eden Prairie, MN. This role requires advanced knowledge of U.S. FDA regulations to oversee regulatory strategies, submissions, and compliance for medical devices. The position emphasizes hands...Senior
- A leading company in the manufacturing sector is seeking a Senior Quality Inspector to ensure product quality and compliance with standards. The role involves complex inspections, quality report analysis, and collaboration with various departments to enhance quality control...Senior
$23.41 - $41.83 per hour
Stryker Corporation in Eden Prairie is seeking a skilled coder to perform inpatient DRG coding and maintain coding standards. The ideal candidate should have 3+ years of experience, a relevant professional certification, and proficiency in coding systems. The role offers...SeniorRemote jobHourly pay$23.41 - $41.83 per hour
Wisconsin Psychiatric Association Inc is seeking a skilled coder to perform inpatient DRG coding while adhering to ethical standards and guidelines. Candidates should hold a relevant professional certification and have at least 3 years of experience in an acute care setting...SeniorRemote jobHourly pay$23.41 - $41.83 per hour
The Texas Health Institute is seeking a professional coder for inpatient DRG coding in Eden Prairie, Minnesota. The role involves adhering to coding guidelines and maintaining performance standards. Candidates should possess a High School Diploma, professional coder certification...SeniorRemote jobHourly pay- The Wisconsin Psychiatric Association Inc is seeking a Senior Inpatient Medical Coder. This remote role requires candidates to provide coding services directly to healthcare providers while upholding high documentation standards. Ideal candidates will have a professional...SeniorRemote jobRelocation package
- A software development company in Eden Prairie is looking for a developer to work on the Spectrum project. The role involves developing and testing new functionalities as well as integrating new data sources and clients. The ideal candidate must have strong SQL expertise...Senior
- Akebia in Eden Prairie, Minnesota is seeking a finance leader to oversee accounting operations. The candidate will lead the accounting team, ensure compliance with SEC regulations, and enhance internal processes. Strong leadership skills and a CPA are required. This role...Senior
$110k - $150k
Description Description Senior Financial Planner & Client Strategist Firm: NewSpring Wealth Partners Location: Minnetonka, MN (hybrid; 3 days/week in-office... ...Benefits - Medical, dental, vision insurance 3% 401(k) Safe Harbor Contribution Life & disability insurance...SeniorWork at officeShift work3 days per week$91.7k - $163.7k
UnitedHealth Group is seeking a Strategic Solution Advisor to function as a subject matter expert in Computer Assisted Coding. This role involves extensive analysis, user acceptance testing, and collaborating with internal teams and client representatives. Remote work...SeniorRemote job$128k - $176k
...This role serves as a Senior Principal Engineer and... ...material SME (subject matter expert) within the Solutions &... ...with business and regulatory objectives across kidney... ...requirements and quality systems (FDA, ICH, ISO, cGxP)... ...PEP"), Vantive's 401(k) retirement savings...SeniorTemporary workWorldwideFlexible hours3 days per week$132.4k - $205.1k
...Senior Principal System Engineer – New Product Development The role is part of the Corporate... ...design reviews. Design systems to meet regulatory requirements. Develop and maintain MS... ...package including health insurance, 401(k), profit sharing, disability, life insurance...SeniorLocal area$20 - $35.72 per hour
UnitedHealth Group in the United States seeks a certified medical coder for a full-time telecommute role focused on facility outpatient coding (ICD-10/CPT). The position requires 3+ years of experience, AHIMA/AAPC credentials, and strong knowledge of coding guidelines. ...Remote jobHourly payFull timeFlexible hours$70.2k - $105.32k
A nonprofit health plan is seeking an experienced financial professional to manage GAAP financial statements and support month-end activities. The role requires a Bachelor's degree in Accounting or related field, with at least 5 years in financial analysis and strong knowledge...Senior$110k - $150k
A financial advisory firm in Minnetonka, MN is looking for a Senior Financial Planner & Client Strategist to enhance client interactions and execute planning strategies. The ideal candidate will have over 5 years of advisory experience, focusing on affluent clients and...SeniorFlexible hours$21.5 per hour
As a Dedicated Meta Technician Expert, you will operate as a highly skilled, autonomous field professional responsible for the end-to-end... ...Health and wellness benefits plans Paid time off and holidays 401(k) with employer matching Paid training, drive time, and mileage...Weekly payFull timeCasual workLocal areaAll shiftsMonday to FridayFlexible hours$23.5 - $31.75 per hour
...proficiency in Microsoft Office, and at least 2 years of purchasing experience. The company offers competitive hourly wages, starting from $23.50 to $31.75, alongside comprehensive benefits including subsidized memberships and a 401(k) plan. #J-18808-Ljbffr Life Time Inc.Hourly payWork at office$132.4k - $205.1k
...Senior Principal Cloud Architect With more than $1B in revenue,... ...adhere to security standards and regulatory requirements Performance &... ...Cloud Platforms: Expert knowledge of at least one major... ...including health insurance, 401(k), disability, life insurance,...SeniorLocal area$85k - $105k
...real company led and staffed by seasoned experts who are also down-to‑earth, good people. We... ...disability/veteran. Job Description Role : Senior Operations Analyst Location : Eden Prairie... ..., or anywhere in between! We offer a 401(k) match on the first 4% of your contributions...SeniorTemporary work- ...The ideal candidate possesses a Bachelor's degree, substantial experience in HRIS administration, and proficiency in payroll processing. Benefits include medical, dental, 401(k), and an Employee Stock Ownership Plan (ESOP). #J-18808-Ljbffr Wunderlich-Malec EngineeringWork at office2 days per week
- Allstartoday in Eden Prairie is seeking a Payroll Specialist to support weekly payroll processing and employee data management. This crucial role ensures employees are paid accurately while adhering to compliance standards across multiple locations. The ideal candidate ...
$105k - $115k
Overview The Senior Development Scientist for Beckman Coulter Diagnostics... ...leadership, maintain regulatory‑compliant documentation, and communicate... ...in compliance with ISO9000/FDA regulations, including... ...dental/vision insurance, and 401(k). Equal Opportunity Employer Danaher...Senior
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Regulatory Affairs Strategist — FDA 510(k) Expert. Be the first to apply!
- senior brand strategist Eden Prairie, MN
- fulfillment expert Eden Prairie, MN
- technology expert Eden Prairie, MN
- guest service support expert Eden Prairie, MN
- senior app developer Eden Prairie, MN
- senior magento developer Eden Prairie, MN
- sr technical product manager Eden Prairie, MN
- senior manager pmo Eden Prairie, MN
- senior accountant part time Eden Prairie, MN
- senior application support engineer Eden Prairie, MN

