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.
- Bracco Medical Technologies is seeking a Principal Regulatory Affairs Specialist to develop and execute regulatory strategies for medical device... ...role requires leading cross-functional teams, coordinating FDA interactions, audits, and regulatory communications while...Senior
- Bracco Medical Technologies is seeking a Principal Regulatory Affairs Specialist in the United States to develop and execute regulatory strategies for medical device products, submissions, and lifecycle changes. The role provides hands-on regulatory support for new product...Senior
- MTS Systems Corporation is seeking a Global Trade Compliance Specialist Senior to support export/import operations and ensure world‑wide regulatory compliance. You will work with Legal, Supply Chain, Sales, Engineering, and Logistics to maintain a robust trade compliance...Senior
$85k - $167.3k
Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need...SeniorWork experience placementInterim roleRemote workFlexible hours$160k - $180k
Senior Manager of Quality and Regulatory Plymouth, MN55441 Posted: 07/09/2026 Employment... ...technology, developing FDA-cleared and... ...based execution of clinical affairs processes, as well as product... ...experience. Expertise in 510(k), PMA, medical devices, Software...SeniorPermanent employmentContract workLocal areaWorldwideFlexible hours- ...Principal Regulatory Affairs Specialist Elucent Medical is a medical device company focused on... ...advanced, specialized knowledge of U.S. FDA medical device regulations, FDA guidance... ...experience preparing and supporting FDA 510(k)s, pre-submissions/Q-submissions, letters...Full timeTemporary workLocal areaFlexible hours
- DriSteem is seeking a Senior Logistics Analyst to develop and optimize our transportation network for both domestic and international shipments. This onsite role in Eden Prairie, MN focuses on improving service-to-cost ratios and managing carrier relationships across regions...Senior
- Carlson Family Office in Minnetonka seeks a senior tax professional to own end-to-end compliance and planning for a multi-generational family. You will work with internal and outside advisors to deliver high-trust tax outcomes. The role emphasizes technical depth, independence...SeniorWork at office
- BCG Attorney Search is seeking an experienced estate planning associate in Eden Prairie, MN to handle complex trusts, estates, and probate matters. The ideal candidate will have four+ years of experience, excellent writing skills, and active Minnesota State Bar membership...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
$106k - $130k
...is the first medical device to receive FDA approval for the treatment of persistent... ...and personally. Position Summary The Senior Regulatory Affairs Specialist originates appropriate documents... ..., which may include US device 510(k), PMA Supplements, EU, Canada, Australia...SeniorTemporary workWork experience placementWork at officeLocal areaWorldwide- 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
$131k - $143k
.....every day!About the RoleThe Principal Regulatory Affairs Specialist develops and executes regulatory... ...for product submissions, including 510(k) Premarket Notifications, EU MDR Technical... ...agencies and Notified Bodies, including FDA interactions, submission reviews, approvals...- Starkey Laboratories, Inc. is looking for a Mechanical Designer at their Eden Prairie headquarters. This role involves designing cutting-edge hearing technologies, collaborating with suppliers, and implementing advanced design techniques using Creo Parametric. The ideal...Senior
- Optum is hiring a Senior Accountant to own the end-to-end accounting function for a range of products and services, ensuring GAAP compliance and accurate financial statements. You will reconcile and analyze general ledger accounts, prepare journal entries, and lead month...SeniorRemote job
- Optum is a global health services organization delivering care aided by technology. This remote nationwide coding role involves assigning medical codes (ICD-10-CM, CPT, HCPCS) from clinical documentation, with a focus on accurate coding for diverse specialties. The position...SeniorRemote job
- UnitedHealth Group is seeking a healthcare coder to identify and assign ICD-10-CM/ICD-10-PCS codes for inpatient hospital services, ensuring correct DRG implications. You will review charts, abstract data, and provide documentation feedback while maintaining coding accuracy...SeniorRemote job
- Optum, part of UnitedHealth Group, seeks a Senior Inpatient Medical Coder/Acute Edits and Denials Claims Analyst to work remotely from anywhere in the U.S. You will correct CCIs, MUE edits, and medical necessity edits while applying ICD-10-PCS and DRG rules to inpatient...SeniorRemote job
- 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
- UnitedHealth Group is seeking a qualified medical coder to assign diagnostic and procedural codes for a nationwide remote role. You will review clinical documentation, perform code checks across specialties, and query providers when information is unclear. Strong knowledge...SeniorRemote job
$94k - $150k
Job TitleSenior Regulatory Affairs SpecialistJob DescriptionSenior Regulatory... ...Affairs Specialist, UltrasoundThe Senior Regulatory Affairs Specialist... ...for agencies such as the FDA, Health Canada, EU Competent... ...device regulatory affairs, with 510(k), and EU MDR Technical...SeniorFull timeWork at officeImmediate startWork visaRelocation package3 days per week- Vortex Doors in Eden Prairie, MN is seeking an Experienced Commercial Door Technician with 4+ years of sectional door and dock experience to install, repair, and maintain commercial and industrial openings. You will diagnose issues, weld dock levelers, and ensure safety...Senior
- Huntington National Bank in Minnetonka, MN is seeking a Sr Financial Recovery Rep (SBA) to develop resolution strategies for classified loans and minimize losses on our commercial loan portfolio. You will analyze financial plans, negotiate loan collections, and oversee ...SeniorRemote job
- American Family Insurance seeks a Senior Product Analyst to guide strategic insurance product development for homeowners, focusing on contract language, underwriting guidelines, pricing analytics, and platform improvements. The role drives profitability, growth, and customer...SeniorContract work
- Medica is seeking a Senior Underwriter to support underwriting for large group commercial customers across Fully Insured and Self Insured products. You will analyze census data and claims experience, develop pricing recommendations, and present sound underwriting rationale...Senior
- Alerus Financial in Minnetonka, MN seeks a Senior Loan Operations Collateral Specialist to administer and safeguard the bank's collateral positions throughout the loan lifecycle. This role executes critical collateral functions including lien perfection, UCC filings, title...SeniorBank staff
$230k - $250k
...everything possible. The Senior Director, Quality... ...site execution, ensures regulatory compliance, and drives... ...Chain, and Regulatory Affairs.This position reports to... ...quality standards (e.g., FDA, ISO, global regulatory... ...vision insurance and 401(k) to eligible employees....SeniorFull timeLocal area- ...compliant documentation, and drive process improvements. You will collaborate with cross-functional teams to harmonize procedures per FDA 21 CFR 820 and ISO 13485, establish key metrics, and train staff in quality methods and data analysis. The role requires extensive...Senior
$94.5k - $171.7k
...spending accounts; paid parking or public transportation costs; 401(k) retirement plan; employee stock purchase plan; life insurance,... ...to pass a drug test before beginning employmentJob Keywords: Senior Product Manager, Health Plan Analytic New Product Solutions, Telecommute...SeniorTemporary workWork experience placementLocal areaRemote workWork from homeFlexible 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
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!
- strategist Eden Prairie, MN
- business strategist Eden Prairie, MN
- investment strategist Eden Prairie, MN
- senior brand strategist Eden Prairie, MN
- technology strategist Eden Prairie, MN
- media strategist Eden Prairie, MN
- strategy consultant Eden Prairie, MN
- communications strategist Eden Prairie, MN
- design strategist Eden Prairie, MN
- guest service support expert Eden Prairie, MN
