Global Regulatory Strategy Lead, Medical Devices
Bracco Diagnostics Inc.
Bracco Medical Technologies seeks a Principal Regulatory Affairs Specialist in Eden Prairie, Minnesota to develop and implement regulatory strategies for medical devices across global markets. The role involves leading 510(k) and EU MDR submissions, coordinating multi-disciplinary teams, and representing regulatory during FDA meetings and audits. The candidate will mentor junior staff and leverage AI tools to improve regulatory deliverables while ensuring compliance with company policies and #J-18808-Ljbffr Bracco Diagnostics Inc.
- Bracco Medical Technologies is seeking a Principal Regulatory Affairs Specialist to develop and implement regulatory strategies across projects and products, partnering with internal and external... ..., and Health Canada submissions, global registrations, and regulatory...RegulatoryMedical device
- TechDigital Group is seeking a regulatory affairs professional... ...the United States to lead pre‑market and post‑... ...submissions for IVD medical devices. The role requires... ...will coordinate with global teams on design dossiers... ...compliant post‑market strategies. The position focuses...RegulatoryMedical device
$165.55k - $260.15k
...everyday technology devices from smartphones... ...are looking for a Global Manufacturing Technology... ...Solutions to lead the development... ...demanding quality, regulatory, operational, and... ...asset and process strategy, including capacity... ...experience, ideally within medical device...RegulatoryMedical deviceFlexible hours$112.7k - $193.2k
...Senior Manager, AI Innovation and Strategy - Life Sciences serves as a... ..., biotechnology, and medical technology client stakeholders... ...approaches to address them; and leads multidisciplinary teams from... ...affairs, pharmacovigilance, regulatory operations, manufacturing, quality...RegulatoryMinimum wageFull timeWork experience placementWork at officeLocal areaRemote work$135k - $145k
...the speed of life.As a global leader in clinical... ...Global Operations PMO and Strategy, responsible for the... ...constructively with Quality, Regulatory, and Operations... ...years of experience in leading medium to large-scale... ...transfer projects in the Medical Device or Diagnostics...RegulatoryMedical deviceFull time- ...Summary As the Director of Regulatory Affairs andQuality Assurance... ...is responsible for ensuring global leadership in RxFunction by... ...for the company's emerging medical device initiatives. This position will... ...to develop the regulatory strategies and to manage all aspects of...RegulatoryMedical device
$113.3k - $226.7k
...Abbott is a global healthcare leader that helps people... ...of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and... ...business and therapy strategy into actionable downstream... ...development Partner with regulatory colleagues in the...RegulatoryMedical deviceLocal areaWorldwide- 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.... ...changes to existing devices, global registrations, audits,...RegulatoryMedical device
$129.3k - $258.7k
...Abbott is a global healthcare leader that helps people... ...of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and... ...annual objectives, goals, strategies, and key initiatives for... ...) regulations, other regulatory requirements, company...RegulatoryMedical deviceFor contractorsWorldwide$159k - $172k
...Why Join Bracco Medical Technologies? We care... ...The Sr. Principal Regulatory Affairs Specialist is... ...and defending complex global regulatory strategies across products, programs... .... This role leads regulatory activities... .... Review device labeling in all forms...RegulatoryMedical deviceNight shift$131k - $143k
Why Join Bracco Medical Technologies? We care as... ...Role The Principal Regulatory Affairs Specialist develops... ...executes regulatory strategies for medical device products,... ...to existing devices, global registrations, audits... ...practices. Experience leading or supporting FDA meetings...RegulatoryMedical device$120k - $150k
...innovating at the speed of life.As a global leader in clinical... ...practical operating constraints.Lead technical capacity reviews at... ...capacity planning, manufacturing strategy, or supply-chain planning.... ..., such as diagnostics, medical devices, life sciences, pharmaceuticals...Medical deviceFull timeShift work$120k - $190k
...CoachJob DescriptionGlobal CAPA CoachThe Global CAPA Coach serves on the Global CAPA Process Team within Philips Quality & Regulatory, developing training and coaching CAPA... ...CAPA Facilitator, Manager, or Owner in the medical device industry, with experience managing...RegulatoryMedical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per week$125.03k - $155k
...in 3D printing!Stratasys is leading the global shift to additive... ...direct-materials sourcing strategy and team. This role is responsible... ...requirements, and applicable regulatory standardsDrive continuous improvement... ..., industrial, aerospace, medical device, or similar...RegulatoryMedical deviceLocal areaShift work- AtriCure, Inc. in Minnesota seeks a Senior Regulatory Affairs Specialist to originate documents to obtain and maintain marketing privileges... ...and other international filings. The role serves as regulatory lead on development projects, supports post-market changes, and...RegulatoryMedical deviceWorldwide
$132k - $160k
Why Join Bracco Medical Technologies? We care... ...! The Principal Regulatory Affairs Specialist... ...implementing regulatory strategies across projects,... ...to existing devices, including development... ...registrations for global product growth and... ...; prepare for and lead meetings /...RegulatoryMedical deviceWorldwide$100k - $125k
...00.00 Evergen is a global industry-leading contract development... ...~ Holiday pay ~ Medical, dental, and vision insurance... ...to align quality strategies with business objectives... ...in the medical device industry. ~ Deep knowledge of global regulatory standards (FDA QSR, ISO...RegulatoryMedical deviceFull timeContract workTemporary workWork at officeRemote workHome office$134.6k - $230.8k
...UnitedHealth GroupOptum is a global organization that... ...will own the product strategy and execution for a... ...legal, compliance and regulatory partners so that PHI handling... ...-market strategy, and leading design discussions3+... ...: provider, payer, medical device, pharmaceutical, or other...RegulatoryMedical deviceMinimum wageFull timeWork experience placementWork at officeLocal areaRemote work$95k - $110k
...Join Evergen? Evergen is a global industry-leading contract development and... ...that power life-changing medical device and regenerative medicine... ...enterprise-wide cybersecurity strategy and continuous improvement... ...security policies, regulatory requirements, and industry...RegulatoryMedical deviceContract workTemporary workRemote work- ...Director of Medical Device Reimbursement and Market Access SANUWAVE... ...Sales, Commercial, Clinical, Regulatory, and Finance to ensure that... ...Develop and execute reimbursement strategies for new and existing medical... ...impact to the business. Lead efforts to obtain, expand,...RegulatoryMedical device
$108k - $205k
...cyber risk. We are a global leader in security operations... ...through industry-leading security operations,... .... The Senior Manager, Strategy, Portfolio Management... ...benefits plan including medical, mental health, dental... ...applicable legal and regulatory requirements. Depending...RegulatoryLocal areaFlexible hours$164.6k - $282.2k
...UnitedHealth GroupOptum Tech is a global leader in health care... ...libraries, schemas and versioning strategy - so that internal teams,... ...to security, privacy or regulatory constraintsDemonstrated ability... ...including provider, payer, medical device, pharmaceutical, or other health...RegulatoryMedical deviceMinimum wageFull timeContract workWork experience placementWork at officeLocal areaRemote work$117.75k - $172.7k
...purpose of this position is to lead technical discussions,... .... In alignment with the Global Account strategies, the position will provide... ...operating procedures, and other regulatory requirements. New... ...component or assembly in the medical device industry. Prefer to have experience...RegulatoryMedical deviceFull timeImmediate start$129.3k - $258.7k
...Abbott is a global healthcare leader that helps people... ...of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and... ...initiatives, audit readiness, regulatory change management,... ...and quality compliance strategy across the EP business...RegulatoryMedical deviceWorldwide$230k - $250k
...the speed of life.As a global leader in clinical... ...translates enterprise quality strategy into disciplined site execution, ensures regulatory compliance, and drives... ...‑functional partners.Lead and be accountable for... ...‑vitro diagnostics or medical device industry, with direct...RegulatoryMedical deviceFull timeLocal area$26.5 - $32 per hour
...methods to support process improvements and regulatory compliance.Ensure documentation records... ..., personal care, food processing, or medical device (preferred).HS Diploma required, but... ...Sick Leave)About ActalentActalent is a global leader in engineering and sciences services...RegulatoryMedical deviceContract workTemporary workDay shift$145k - $200k
...the OpportunityAn innovative medical device organization is seeking a... ...Management System (QMS) compliance, regulatory strategy, audit readiness, and... ...Cities campus environment.Lead implementation and... ...compliance with FDA, ISO, and global regulatory requirements.Provide...RegulatoryMedical deviceFlexible hours$159.3k - $273.2k
...Director, Innovation and Strategy - Life Sciences within... ...Strategy, you will lead the design, packaging,... ...pharmaceutical, biotechnology, and medical technology partners... ...impact outcomes across global health communities.You'... ..., cybersecurity, regulatory validation, GxP, or responsible...RegulatoryMinimum wageFull timeWork experience placementLocal areaRemote work$99.3k - $198.7k
...Full timeAbbott is a global healthcare leader that... ...spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and... ...technical, clinical, regulatory, quality, schedule, and... ..., and risk mitigation strategies to ensure successful...RegulatoryMedical deviceShift work$134.6k - $230.8k
...Director, AI Innovation and Strategy - Life Sciences... ...pharmaceutical, biotechnology, and medical technology... ...In this role, you will lead multidisciplinary client... ..., and directly improve global health outcomes.You'll... ...affairs, pharmacovigilance, regulatory operations,...RegulatoryMinimum wageFull timeWork experience placementWork at officeLocal areaRemote work
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