Regulatory Strategy Lead, Medical Devices Compliance
Semler Scientific Inc
Semler Scientific Inc in Dallas, Texas is seeking a Senior Regulatory Affairs Specialist who will play a key role in regulatory strategy and compliance throughout product lifecycles. Responsibilities include participating in compliance audits, supporting product development in navigating FDA regulations, and assisting with preparing regulatory filings. The ideal candidate must have over 10 years of experience in regulatory affairs, a BS in a health profession or science, and strong analytical and communication skills. #J-18808-Ljbffr Semler Scientific Inc
$111k - $167k
...predictive, and precise.DescriptionThe Regulatory Compliance Lead is a technically grounded individual... ...across consumer, research, and medical device (SaMD) product areas. This role partners... ...and developing proactive mitigation strategies to maintain a strong regulatory...RegulatoryMedical deviceFull time$163.4k - $322.1k
...Summary The Experience Design Strategy Manager is a client-facing... ...you will be responsible for: Leading engagements that define... ...Team An evolving customer and regulatory landscape, mounting pipeline... ...firms to global big pharma to medical device companies, to drive business...RegulatoryMedical deviceLocal areaFlexible hours$198.7k - $391.6k
...Summary The Experience Design Strategy Senior Manager is a client-... ...at the executive level and leading cross-functional teams through... ...An evolving customer and regulatory landscape, mounting pipeline... ...firms to global big pharma to medical device companies—to drive business...RegulatoryMedical deviceLocal area- ...design and business strategy for cutting-edge biotech... ..., manufacturing, and compliance in a rapidly evolving... ..., biotechnology, and medical device sectors. This will be... ...industry trends and regulatory changes to ensure... ...class biotech facilities.Lead design proposals for...RegulatoryMedical device
- Verily Health is seeking a Quality Systems and Compliance Lead to own one or more QA domains and drive strategic initiatives... ...spanning consumer health, research tools, and medical devices meet quality, reliability, and regulatory standards. You will lead the QMS, maintain ISO 13...RegulatoryMedical device
$142k - $213k
...precise.DescriptionThe Quality Systems and Compliance Lead drives quality excellence at Verily... ...consumer health, research tools, and medical devices are developed, commercialized, and... ...of quality, reliability, and regulatory compliance.ResponsibilitiesLeads the...RegulatoryMedical deviceFull time- The Regulatory Affairs Specialist 3 develops and executes regulatory strategy and integrates regulatory requirements... ...for regulatory compliance. Uses technical knowledge... ...and registration of medical devices. Trains and mentors... ..., etc.Manages and leads responses to Regulatory...RegulatoryMedical device
- Larson Maddox is seeking a Compliance Lead in Dallas, TX, to advance the company’s regulatory program across business operations. The role partners with stakeholders to identify risks, ensure regulatory obligations are met, and promote a strong ethics culture. The ideal...Regulatory
$88.6k - $246.6k
...Solution Implementation Lead is the end‑to‑end... ...operationalization of new connected medical device and digital health... .... The role bridges strategy, execution,... ...operational workflows, regulatory considerations, and... ...ensure regulatory and compliance requirements are met...RegulatoryMedical deviceFull timePart timeImmediate startRemote workWorldwide- ...experienced and highly motivated Regulatory Manager to join our... ...and executing regulatory strategies to ensure compliance and successful product... ...regulatory agencies, and lead cross-functional teams to... ...pharmaceutical, biotech, or medical device industries. ~ In-depth...RegulatoryMedical deviceContract workWork at office
- ...Responsibilities:This position leads project submissions for regulatory approvals and acts... ...global regulatory strategies for new and modified medical devicesPrepares robust... ...teamsReviews device labeling and marketing materials for compliance with FDA submissions and...RegulatoryMedical deviceFor contractors
- ...seeking a detail-oriented Regulatory Associate to join our Regulatory... ...documents, ensuring compliance with all regulatory standards... ...and contribute to regulatory strategies across a variety of... ...pharmaceutical, biotech, or medical device industries. ~ Familiarity...RegulatoryMedical deviceContract workWork at office
- ...pharmaceutical, biotechnology, and medical device companies across the drug... ...Business Development to lead commercial expansion across... ...microbiology testing, and regulatory compliance consulting , and a proven... ...business development strategy targeting biotech, pharmaceutical...RegulatoryMedical deviceFull timeContract workRemote work
- A medical device company in Addison, TX is looking for a Regulatory Affairs Specialist 3 to develop regulatory strategies and ensure compliance with FDA and international regulatory requirements. The ideal candidate will have over 5 years of experience in regulatory affairs...RegulatoryMedical device
$200k - $220k
...to execute the brand strategy, positioning Alkermes... ...professional pharma/medical device experienceDriver's license... ..., sales training, compliance, medical affairs,... ...market access)Ability to lead without authority... ...regarding the legal and regulatory environment regarding...RegulatoryMedical deviceWork at officeNight shift- Regulatory Affairs ConsultantLocation: Hybrid (Dallas, TX Preferred... ...our dynamic team in the medical device sector. This role will provide... ...landscapes, ensuring compliance with global medical device... ...facilitating market entry strategies. The ideal candidate will have...RegulatoryMedical deviceFull time
$130.7k - $196.1k
...Transformation and Supply Chain (TSC) Strategy Team: AT&T’s TSC Strategy... ...Role and Responsibilities of Lead Business Strategy: Our Lead... .../training.Perks and Benefits:Medical/Dental/Vision coverage.401(k)... ...a chance to change the world.Compliance: AT&T will consider for...Temporary workWork at officeLocal areaRelocation- ...Regulatory Affairs Professional We are looking for an energetic and self-motivated... ...Seeking expert advice and develops device regulatory product strategies and identifies data and information... ...in IVD, companion diagnostics, medical devices (Preferred experience: 7+ years...RegulatoryMedical deviceWork experience placementWork at office
$118.3k - $207.4k
..., build better judicial and regulatory systems. We help them get it... ...) HIPAA/HITECH Act and GDPR compliance, and (iii) health care laws... ...including but not limited to medical device regulations applicable to clinical... ...and product development strategy.We are an incredibly...RegulatoryMedical deviceFull timeWork at office- Description The Senior Regulatory Affairs Specialist is... ...regulatory strategy and compliance across the product lifecycle... ...Ensure procedural, medical, scientific, and economic... ...ISO 13485:2016 Lead Auditor Certification... ...II software medical device organization Familiarity...RegulatoryMedical device
$164.6k - $274.4k
...want to hear from you.Title: Lead Counsel, Digital Marketing &... ...advertising technologies, marketing compliance, and consumer protection... ...will bring: Strong legal, regulatory, and technical judgment, including... ...segmentation, targeting strategies, analytics, and measurement tools...RegulatoryFull timeFixed term contractWork at officeRemote work- ...Fargo is seeking a Senior Lead Business Execution... ...does not own product strategy, but serves as a key enabler... ..., timelines, and regulatory expectationsLead leadership... ...risk mitigating and compliance-driven culture which... ...request a medical accommodation during the...RegulatoryFull timeWork experience placementWork at office
- ...Dallas, TX is seeking a Collections Team Lead to supervise early- and mid-stage... ...collections function. You will ensure regulatory compliance with CFPB, FDCPA and investor guidelines... ...outcomes through effective engagement strategies. The role requires strong collections...Regulatory
$164.6k - $274.4k
...want to hear from you. Title: Lead Counsel, Digital Marketing &... ...advertising technologies, marketing compliance, and consumer protection... ...will bring Strong legal, regulatory, and technical judgment, including... ...segmentation, targeting strategies, analytics, and measurement tools...RegulatoryFixed term contractWork at officeRemote work- RoShay Services in Dallas seeks an experienced Regional Safety Manager to lead EHS initiatives across multiple states, ensuring a proactive safety culture and regulatory compliance. You will develop programs, conduct audits, lead investigations, deliver training, and travel...Regulatory
$95k - $125k
...+ Bonus + Benefits About Our Client Compliance Lead Our client is a growing owner and operator... ...focus on operational excellence, regulatory integrity, and long-term asset performanorganizationnization... ...and assist in developing mitigation strategies Partner with business and operational...Regulatory- ...International Tax Specialist to manage U.S. international tax compliance for foreign entities and to help optimize tax positions across... ...collaborative, growth-oriented environment. The role emphasizes planning strategies, staying current with tax laws, and supporting audits and...
$185.5k - $344.5k
...Director, Future Field Engagement Strategy - Metrics & Incentives Job Description Summary... ...Key Responsibilities: Architect and lead futureready measurement frameworks that... ...dispersed teams. Candidates from medical devices, diagnostics, life sciences services, insurance...Medical deviceRemote workVisa sponsorshipRelocation package- A leading compliance technology firm is seeking a Manager, Growth & Strategy to oversee business development initiatives and client engagement. The ideal candidate will have over 5 years of experience in the digital technology or financial sectors, with strong communication...Full time
- ...We are hiring an Executive Director to lead program execution and strategic... ...deliveryEnsure program readiness across safety, regulatory, and compliance requirementsWhat You Bring10+ years... ...to power generation, energy strategy, or critical facility operationsHow We...Regulatory
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