Post-Market Safety & Risk Lead - Medical Devices
Katalyst CRO
Katalyst CRO is seeking a experienced Post Market Surveillance (PMS) Specialist in the United States. You will manage post-market product safety surveillance and risk management activities, coordinate with Medical Affairs, Clinical Affairs, R&D, and complaint handling, and drive PMS plans and PSURs end-to-end. The role requires 4–8 years in PMS within FDA/EU-MDR regulated medical device environments, with knowledge of relevant regulations and standards. #J-18808-Ljbffr Katalyst CRO
- ...responsible for managing activities related to post-market product safety surveillance and risk management. Serves as a liaison between Medical Affairs, Clinical Affairs, Research &... ...within FDA/EU-MDR regulated Medical Device environments with a focus on post-market...RiskMedical device
- ...About The Job The Marketing Manager efdoralprin Alfa will support the... ...report to the Global Brand Lead, efdoralprin alfa. Join the team... ...pharmaceutical / biotech or medical devices industries Experience with... ...stakeholders; proactively flags risks and proposes solutions before...RiskMedical deviceLocal area
$180k - $200k
...Overview: We are seeking a seasoned Market Regulatory Affairs Manager to lead and evolve our post-market regulatory affairs team... ...in a high-volume IVD or medical device environment . You will lead a team... ...stakeholders, ensuring regulatory risk is communicated clearly and...RiskMedical deviceFull timeContract workRemote work- ...you will do: The Global Safety Program Lead, Senior Director is accountable... ...to optimize benefit risk and maintain a competitive... ...SARB, FSIRB, and DSMB/DMC, Medical Affairs Review Committees (... ...studies, communication and post-marketing surveillance, epidemiology,...RiskHourly payTemporary workLocal area
- ...European Commission, providing CE/MDR and other medical device certifications that allow manufacturers to access the European market. The company is expanding its presence in... ...will build relationships, generate leads, and represent the company at industry events...Medical deviceContract workWork at officeLocal areaRemote work
$175k - $225k
...rapidly growing, Boston-based medical technology company using... ...on cardiovascular care - leading to better patient outcomes... ...experience in the medical device industry and 2–5+ years of... ...including audits, CAPA, risk management and post-market compliance requirements such...RiskMedical deviceWork at officeLocal areaRemote workFlexible hours- ...existed before: a consumer device that performs complex... ...rigor of a regulated medical device environment without... ...DHFs, DMRs, V&V plans, risk files; you’ll ensure... ...done this before. You’ll lead quality strategy and... ..., V&V, production, and post‑market data. Audits & Inspections...RiskMedical deviceDay shift
- ...Ambulatory Monitoring & Diagnostics to lead global regulatory strategy,... ...Regulatory Affairs professionals and drive risk mitigation, submissions, and market access decisions. The role... ...extensive regulatory knowledge for medical devices, strong leadership, and the ability...RiskMedical device
$140k - $155k
...Promotional Planning & Marketing Operations... ...Marketing Operations leads Vericel’s marketing... ..., including the Medical, Legal and Regulatory... ..., timelines, risks and dependencies to... ...biotechnology, medical device, or another... ...the time of this posting is $140,000 to $15...RiskMedical deviceFor contractorsWork at officeRemote work- ...Medical Device Senior Manufacturing Engineer Canon USA's Boston Incubation... ...optimal providers. Lead and collaborate with contract... ...manufacturing. Deploy manufacturing risk assessment and mitigations,... ..., clinical specialists, marketers, buyers, and others. Results...RiskMedical deviceContract workWork at office
$78k - $113k
...POSITION SUMMARY: The Risk Management... ...liabilities within Boston Medical Center (BMC) and... ...culture of safety. The Risk... ...Case Management Leads investigations (... ...with Safe Medical Devices Act (recalls) Keeps... ...action plans post-SREs Identifies... ...internal equity, and market-competitiveness....RiskMedical deviceWork experience placementWork at officeFlexible hours$90k - $165k
...testing and verification of software as a medical device, medical device systems and software... ...value in client engagements • Reviewing risk analysis and experience working on FMEA'... ...determined by factors such as experience, location, skills, education, and market conditions....RiskMedical device- ...organization responsible for maintaining existing medical device products across sports medicine and soft... ..., manufacturing, regulatory affairs, marketing, R&D, and quality teams to support design and process changes, perform risk management activities, execute product...RiskMedical device
- ...Sector: Medical TechnologyReference: BBBH _ Shape the Future of Medical Device Innovation We're seeking a talented and detail-oriented... ..., and compliant products to market. The Role As a Senior Design Assurance... ...control requirements, and risk management processes. Key Responsibilities...RiskMedical device
- ...experience within the biotech, pharmaceutical, or medical device industry. ~ Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis required. ~ Expertise in... ...of our reward pillars. This includes a market competitive base salary and annual incentive...RiskMedical deviceWork at officeRemote workWork visaFlexible hours
- ...demonstrated experience leading an organization... ...enterprise strategy, capital markets positioning, and... ...Experience in MedTech, Medical Devices, or Diagnostics is preferred... ..., both pre- and post-IPO. Lead the organization... ...performance, risks, and strategic recommendations...RiskMedical deviceFull timeRemote work
$160k - $183k
...partners, we offer the leading at-home EEG platform... ...execution of next-generation medical devices that meet user needs,... ...usability, technical risk, manufacturability,... ...technology, or other safety-critical products preferred... ...using current market compensation data for...RiskMedical deviceContract workWork experience placementWork at officeRemote workFlexible hours$150k - $195k
...Senior Reliability Engineer to lead the charge in ensuring our... ...technical expertise to data-driven, risk-informed decisions and... ...Product Introduction (NPI), in-market monitoring (ORT/ Field... ...consumer electronics or wearable/medical device environments ~ Bachelor's or...RiskMedical deviceFull timeWork at officeRelocation- ...ages 40+ Industry Medical Practice Type Privately... ...Categories Medical Devices Manufacturing... ...Sales - Health Plans to lead the national expansion... ...involves owning the go-to-market strategy, winning new... ...Experience with value-based or risk-aligned partnerships is...RiskMedical device
$87k - $117k
...Enterprise Market Risk Management - Liquidity Risk Management Treasury Oversight Analyst Citizens Enterprise Market Risk Management, a... ...skills and experience. We offer competitive pay, comprehensive medical, dental and vision coverage, retirement benefits, maternity/paternity...RiskH1bWork at officeLocal areaWork visaFlexible hours- ...entrepreneurs and the world's leading companies.... ...Advances in connected devices, remote diagnostics, and... ...and find early product market fit. This is a hands on... ...developing innovative health/medical devices are considered... ...with taking calculated risks and learning fast Wanting...RiskMedical deviceContract workFreelanceRemote workWork from home
$75k
...BONE is a fast-growing, publicly traded medical device company that is an industry pioneer in minimally... ...device organization whose products are marketed to a medical specialty practice and... ...product advocates There are potential risks associated with the iFuse Implant System...RiskMedical deviceLocal areaWorldwide- ..., and lifecycle management of Class II medical devices. Provide regulatory guidance during product... ..., responses to FDA questions, and post-market regulatory activities etc) under the direction... ...regulatory input to design controls, risk management, change control, and post-...RiskMedical device
- ...the Company Dynamic manufacturer & marketer of medical devices Industry Medical Devices Type... ...three critical domains. This includes leading the security efforts for manufacturing... ...operations, and maintaining a comprehensive risk management framework. The VP will also...RiskMedical device
- ...POSITION SUMMARY: The Associate Market Manager plays a key role in the overall management... ...include retaining employees, managing risk, driving revenue growth, increasing profitability... ...and RESPONSIBILITIES: Leadership: Leads by example by maintaining a positive...RiskLocal area
$42 - $47 per hour
...with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices... ...serve life sciences clients in six global markets: United States, Puerto Rico, Dominican... ..., may be exposed to fumes and the risk of electrical shock, and occasionally work...RiskMedical deviceHourly payFor contractorsFor subcontractorWork at office- ...Verification & Validation (V&V) activities for medical device products. The role involves planning and... .... Support design verification, risk management, and product validation... ...Preferred: Previous experience with client or other leading medical device manufacturers....RiskMedical device
- ...POSITION SUMMARY: The primary focus of the Market Manager role is to drive revenue, increase... ...branches in the market, and manage risk within their branch and other assigned branches... ...and training. Leadership: Leads by example by ensuring that the Branch Manager...RiskTraineeshipWork at officeLocal area
$90k - $130k
...the Hardware Product Team to lead engineering evaluation of new technologies, addressing risks that build confidence in NPI readiness... ...electronics, wearables, or medical devices. ~ Experience with... ...the future to reflect evolving market conditions and organizational...RiskMedical deviceFull timeContract workWork at officeRelocation$241.95k - $311.54k
...of life's most critical medical moments. If you're... ...Increasing revenue and driving market development through... ..., medical or surgical devices Lives within the... ...on top of (3) industry leading company benefits (free... ...capable of assessing fetal risk for both common...RiskMedical deviceRemote workWorldwideFlexible hours
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