Senior Medical Writer - Clinical Evaluation & Regulatory
Dormont Manufacturing Co
Abbott is seeking a Senior Medical Writer in Maple Grove, MN, to provide expertise throughout the product development lifecycle. This role involves authoring Clinical Evaluation Reporting documents for various medical products and requires strong writing and communication skills. The ideal candidate will have at least a Bachelor’s degree in Science or Medical Technology and a minimum of three years in a relevant field. Abbott offers competitive compensation and a supportive work environment. #J-18808-Ljbffr Dormont Manufacturing Co
$78k - $156k
...you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP)... ...currently has an on‑site opportunity for a Senior Medical Writer, Clinical Evaluation. The Sr. Medical Writer on our Regulatory Clinical Evaluation team provides technical...SeniorRegulatoryWork experience placementShift work- Venture Med Group is seeking a Senior Clinical Research Associate (Sr. CRA) responsible for planning... ...clinical sites, ensuring FDA regulatory compliance, and collaborating with CROs... ...should possess a Bachelor’s degree in a medical/scientific field, have significant clinical...SeniorRegulatory3 days per week
- Laborie Medical Technologies Corp in Minnetonka, MN is seeking a Medical Writer II to develop clinical and regulatory documents and presentations. This role involves collaboration with internal and external partners to support technical writing functions for Clinical and...Regulatory
- ...Our client is an early-stage medical device company, whose commitment lies in developing... ...of life. Position Description The Senior Clinical Research Associate (Sr. CRA) assists with... ...accordance with FDA Regulations, other global regulatory bodies, GCP and ISO compliance, and...SeniorRegulatoryShift work3 days per week
$106k - $130k
AtriCure, Inc. seeks a Senior Clinical Research Associate (Sr. CRA) in Minnetonka, Minnesota.... ...clinical trials, ensuring compliance with regulatory standards while leading junior team... ...$130,000 USD, with benefits including medical, dental, and 401K. #J-18808-Ljbffr Atricure...SeniorRegulatory$82.6k
About the role We are looking for a Senior Clinical Research Specialist to join our Urology Biostatistics... ...(ICD‑10‑CM, ICD‑10‑PCS, CPT, etc.) and medical terminologies (SNOMED, LOINC, RxNorm,... ...clinical safety, quality assurance or regulatory affairs) or an advanced degree (PhD,...SeniorRegulatoryWork experience placementWork at office3 days per week- ...Passion. Who We’re Looking For: The Medical Writer II collaborates in the development and execution of clinical, scientific, and regulatory documents and presentations for internal... ...plans and reports, clinical evaluation plans and reports, reports and study protocols...RegulatoryFlexible hoursShift work
- ...manufacturing, such as manufacturing readiness, audits, and clinical builds to ensure a smooth transition and continuously accurate... .... Review and approve protocols, reports, and change orders. Evaluate regulatory impact of equipment changes prior to implementation. • NC...SeniorRegulatory
$106k - $130k
...Synergy™ Ablation System is the first medical device to receive FDA approval for the... ...professionally and personally. Position Summary The Senior Clinical Research Associate (Sr. CRA) at... ...members and ensuring compliance with regulatory standards and protocols. The Sr. CRA is...SeniorRegulatoryTemporary workInterim roleWork at officeLocal areaWorldwide$75.1k
...Hills; US-MN-Maple Grove Senior Product Analyst - 12... ...to determine regulatory reportability and coordinates... ...business operations. Apply clinical knowledge related to product application to evaluate identified complaints.... ...regulations. Author Medical Device Reports (MDRs),...SeniorRegulatoryWork at office- ...Senior Clinical Research Associate We believe that great healthcare is an essential safeguard... ...will play a critical role in advancing medical devices from concept through... ...leadership in evidence generation to meet regulatory and commercialization needs. The Sr. CRA...SeniorRegulatoryLocal area
$137.7k
...Associate Director, Medical Affairs & Clinical Strategy Onsite Location(s): Maple Grove, MN, US, 553... ...communications, ensuring alignment with regulatory standards and publication excellence... .... Boston Scientific continues to evaluate its policies and protocols regarding...RegulatoryHourly payWork at officeShift work- ...Minnesota. In this role, you will lead audits of metal suppliers to ensure compliance with regulatory requirements and Boston Scientific's standards. You will also be responsible for evaluating supplier capabilities and leading cross-functional projects to enhance quality...SeniorRegulatory
- ...structural heart technologies. The company seeks professionals for Clinical & Regulatory Affairs roles to support clinical research and regulatory... ...opportunities. Candidates with experience in Class III medical devices are especially encouraged to apply. #J-18808-Ljbffr...Regulatory
$131k - $151k
...Anteris is seeking a Senior Usability/Human Factors... ...requirements. Prototyping & Evaluation Prototype novel... ...with ISO and regulatory standards (e.g., FDA Human... ...engineering, marketing, clinical, and regulatory teams... ...usability engineering for medical devices. Experience...SeniorRegulatoryFull timeTemporary workH1bLocal areaVisa sponsorshipWork visaFlexible hours- Senior System Design Quality Engineer - Interventional Cardiology... ...product development and ensure regulatory compliance. Work Mode This... ...management of next‑generation medical devices. Ensure compliance with... ...60601‑1 and IEC 62304. Apply clinical knowledge to influence device...SeniorRegulatoryRelocation package3 days per week
$102.1k - $194k
...Responsibilities Represent the Regulatory Affairs function on cross‑... ...prepare submissions for Class II medical devices. Create innovative... ...Operations, Medical Safety and Clinical teams. Prepare, coordinate... ...and post‑market activities. Evaluate product and manufacturing changes...RegulatoryWork at officeLocal areaOverseas3 days per week$99.2k - $148.8k
...developing innovative medical technologies that improve... ...A Day in the Life The Senior Supplier Quality... ...program timelines and regulatory requirements. The ideal... ...and communication, and evaluating the impact of Supplier... ...requirements at the hospitals or clinics they support. This...SeniorRegulatoryFull timeH1bWork at officeLocal areaImmediate startFlexible hours- Boston Scientific is seeking a Fellow in Regulatory Affairs based in Maple Grove, MN. This role involves leading regulatory strategies... ...of experience, particularly with FDA interactions for complex medical devices. The position operates under a hybrid model, requiring...SeniorRegulatoryWork at office3 days per week
$90k - $115k
...Events and Serious Adverse Events from clinical studies. Evaluate source documentation for completeness... ...and reporting deadlines to ensure regulatory compliance. Prepare safety narratives... ...comprehensive benefits package that includes medical, dental, vision, retirement savings,...RegulatoryWork at officeFlexible hours- B Capital in Maple Grove, Minnesota, is seeking a Principal Regulatory Affairs Specialist to join their Interventional Oncology and Embolization team. This role is responsible for planning and managing regulatory submissions to FDA and EU, supporting new product development...SeniorRegulatoryWork at office3 days per week
$82.6k - $156.9k
B Capital is seeking a Senior Clinical Research Specialist for its Urology Biostatistics and Real World Evidence team. This hybrid role, requiring... ...and four years of experience in related fields, expertise in medical coding systems, and coding definitions for Urology....SeniorWork at office3 days per week- Consultant, Clinical Project Specialist, Medical Devices Summary Our client, a Fortune 500 Medical Device Company , has engaged GForce Life Sciences... ...international Good Clinical Practices, and applicable regulatory standards. This role’s dedicated focus is on study management...RegulatoryFull timeContract work
$82.78k - $140.72k
We are searching for a Senior Subcontracts Administrator at our Combat Mission Systems... ...solicitation packages to subcontractors, evaluation of subcontractor proposals, price analysis... ..., & Skills A clear understanding of regulatory and trade compliance, particularly with...SeniorRegulatoryFull timeContract workWork experience placementFor subcontractorWork at officeLocal area- ...redefine expectations in the treatment of aortic stenosis. Our Clinical and Regulatory Affairs teams play a critical role in supporting clinical... ...compliance Clinical trial management within the medical device industry Roles in Clinical & Regulatory Affairs include...RegulatoryTemporary workLocal areaWorldwideFlexible hours
- Medica is actively seeking a Manager, Pharmacy Clinical Governance, to lead the clinical pharmacy... ...Minnetonka, MN. The position requires managing drug evaluations, developing clinical criteria, and ensuring alignment with regulatory standards. The ideal candidate must possess...Regulatory
- Cypress HCM is seeking a Clinical Safety Specialist in Maple Grove, Minnesota, to manage Adverse Events from clinical studies. This role... ...safety documentation, and ensuring compliance with regulatory standards. The ideal candidate holds a Bachelor's degree in Nursing...Regulatory
- Boston Scientific is looking for a Senior Product Analyst for a 12-month defined term position in Maple Grove, MN. This role involves analyzing customer complaints to ensure regulatory compliance and coordinating activities with internal teams and customers. Responsibilities...SeniorRegulatory
- ...seeking a highly experienced Senior Data Analyst with strong expertise in healthcare data, clinical data warehousing, and quality... ...data-driven decision-making and regulatory reporting in a healthcare-focused... ...working with Electronic Medical Records (EMR/EHR) systems...SeniorRegulatory
- ...Grove is seeking an experienced Home Care Registered Nurse (RN) Manager to lead Clinical Operations and drive agency growth. The ideal candidate will have a strong background in regulatory compliance and clinical leadership. The position offers a competitive salary, flexible...RegulatoryFlexible hours
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