Regulatory Affairs
748 open positions
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Biologe (m/w/d) implantcast GmbHBuxtehude, NIEDERSACHSEN 1mo Leading the Biological Affairs team to plan, steer, and ensure quality of biological evaluations for medical devices throughout their lifecycle, assessing biological risks, and deriving appropriate measures.
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Senior Research And Development Engineer↗ Barrington JamesShannon, County Clare, Ireland 1mo Lead end-to-end development of next-generation implantable bone regeneration devices from concept to launch.
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Senior Systems Engineer – Aesthetic Filler & Combination Products (all genders)(full-time, regular) AbbVieLudwigshafen, RP, de 1mo Senior Systems Engineer leading the development of aesthetic devices and therapeutic combination products (e.g., syringes, autoinjectors, electromechanical pumps) for clinical and commercial programs.
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Staff Clinical Evaluation Specialist StrykerGurugram, India 1mo Develop clinical evidence strategies and documentation to validate device safety and performance for regulatory submissions.
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https://innolitics.com/join at Innolitics InnoliticsRemote 1mo Building AI-enabled regulated medical software for US market entry, focusing on high-quality code and regulatory submissions.
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Staff Specialist, Post Market Quality BdxUSA CA - San Diego Bldg A&B 1mo Global subject matter expert driving post-market quality activities, field actions, and regulatory compliance for Medication Management Solutions.
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Standortleitung AEMP (m/w/d) am Standort Langen Asklepios Service Reinigung GmbH Alsbach-HähnleinLangen (Hessen), HESSEN 1mo Leading the Medical Device Reprocessing (AEMP) site at Langen, ensuring safe, compliant, and efficient reprocessing of medical devices.
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Associate Principal Scientist, Combination Product Design Verification (Associate Director Equivalent) MsdUSA - New Jersey - Rahway 1mo Lead end-to-end design verification strategies, test method development, and validation for novel biologic/drug/vaccine-device combination products to ensure clinical readiness and commercialization.
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Regulatory Affairs Specialist III – Diabetes Care (on-site) AbbottUnited States - Illinois - Buffalo Grove $68k–$136k1mo Supports manufacturing/operations day-to-day activities for change control and provides regulatory direction on team activities for diabetes care products.
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Senior Manager, Regulatory Affairs AdaptivebiotechnologiesRemote (WFH) $145k1mo Leads ex-US regulatory strategy for NGS-based in vitro diagnostic (IVD) products and companion diagnostics, focusing on EU IVDR and Health Canada while managing biopharma co-development partnerships.
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Head of Product Development↗ Network Scientific RecruitmentEngland, United Kingdom 1mo Lead a team of scientists and engineers to develop new medical devices from concept through regulatory approval to full-scale manufacturing.
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Regulatory Affairs Intern ResmedRemote 1mo Support the LATAM Regional Regulatory Affairs team with routine product submissions to obtain regulatory market access for innovative medical and non-medical software and systems across Latin America.
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薬事スペシャリスト（医療機器）／Vision ZeissgroupTokyo, JP 1mo Managing regulatory submissions and compliance for Class I medical devices in Japan, including strategy formulation and maintaining licenses.
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Staff Product Engineer, Tray & Packaging MarmonHillsboro, OR, US 1mo Develops, designs, and tests sterile and non-sterile packaging solutions for medical devices to protect them during transport, storage, and surgery.
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Technischer Redakteur (w/m/d) - Biomechanik N.O.C Engineering GmbHTuttlingen, BADEN_WUERTTEMBERG 1mo Technical liaison between the biomechanics testing area and the regulatory approval department for joint and spine implants.
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Senior Manager (Level 1), Regulatory Affairs CMC MyhrabcAPAC > India > Noida 1mo Lead regulatory affairs projects for human and veterinary medicinal products, medical devices, and related categories, focusing on CMC aspects and client relationship management.
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Research and Development Lead↗ Hero Recruitment 1mo Technical leader driving the development of drug-device combination products, focusing on the drug side, stability studies, and analytical test methods for APIs.
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Compliance Engineer, Product Safety & Compliance PhilipsNew Kensington, Pennsylvania, United States $74k1mo Ensure global product safety and regulatory compliance for Sleep & Respiratory Care medical devices through testing, design reviews, and certification management.
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Principal Scientist- Med Device Mircobiology EurofinsLancaster, PA, us 1mo Provide scientific leadership and guidance on medical device reprocessing and microbiology testing programs, serving as a technical subject matter expert for audits and client interactions.
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Associate Director, Human Factors Engineering CslEMEA, DK, Kgs. Lyngby, CSL Behring 1mo Lead the integration of human factors engineering and usability strategies for medical devices, combination products, and healthcare technologies to ensure product safety, effectiveness, and user-friendliness.
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Senior Regulatory Affairs Specialist MedtronicGurgaon, Haryana, India 1mo Senior Regulatory Affairs Specialist managing product registrations, licenses, and compliance for medical devices in India.
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Senior Medical Director SmithnephewFort Worth, US $195k–$321k1mo Provide expert medical guidance and leadership across the full product life cycle for Smith+Nephew's Advanced Wound Management franchise, covering device, pharmaceutical, biologic, and combination-product activities.
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Senior Regulatory Affairs Specialist Pascall Systems, Inc.Remote 1mo Guide product, quality, and clinical plans through regulatory pathways for an FDA-cleared, EEG-based brain state monitoring platform (wearable sensor + Android app) to ensure safe, effective, and compliant medical device development.
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Clinical Evaluation↗ Meril Life SciencesGJ, IN 1mo Lead end-to-end clinical evaluation and evidence strategy for Class III implantable medical devices in compliance with EU MDR.
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EU Post Market Surveillance Specialist IntuitiveMadrid, SPAIN, es 1mo Evaluates medical device complaints, determines vigilance reporting requirements, and conducts follow-up investigations to support regulatory compliance.
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Segment Manager Medical Devices Benelux SgsSpijkenisse, ZH, nl 1mo Develop and execute the Medical Devices growth strategy for Benelux, owning the segment P&L, revenue growth, and profitability.
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Director, Regional Device & Drug Delivery Center of Excellence (RTC) PciservicesStamullen, Co. Meath, IRL, IE 1mo Lead the design, assembly, validation, and regulatory strategy for drug delivery devices (autoinjectors, pens) and container closure systems for biopharma clients.
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Sustainability & ESG Specialist (m/w/d), PAJUNK® GmbH Medizintechnologie (KH) PAJUNK® GmbH MedizintechnologieGeisingen, Baden, BADEN_WUERTTEMBERG 1mo Implementing and tracking ESG and sustainability measures across the medical device company, coordinating requirements for supply chain and packaging projects, and managing regulatory compliance.
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Graduate Systems Engineer - Boston Scientific 2027 Graduate Programme, Clonmel BostonscientificClonmel, Ireland | N/A 1mo Support the development of complex active implantable medical devices by applying systems engineering methodologies and design controls.
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Medical Writing Specialist↗ Zimmer BiometBengaluru, Karnataka, India 1mo Independently authors regulatory clinical documents and executes literature strategies for medical device compliance.
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Especialista em Desenvolvimento de Produto↗ ClearCorrectCuritiba, Paraná, Brazil 1mo Lead product development projects for dental implants and medical devices, translating user needs into technical specifications and ensuring regulatory compliance.
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Director, Regional Device & Drug Delivery Center of Excellence (RTC)↗ PCI Pharma ServicesStamullen, County Meath, Ireland 1mo Lead a Center of Excellence for device assembly, testing, validation, and regulatory strategy for combination products and drug delivery systems.
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Senior Consultant – CRA & AI Act Pharma & MedTech Knightec Group Compliance and Management ABGöteborg, Sweden 1mo Lead GAP analyses and support customers in classifying AI systems and connected medical devices against the EU Cyber Resilience Act (CRA) and AI Act.
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Regulatory Affairs Manager/Senior Manager – CMC & Regulatory Change Management - FSP Thermo Fisher Scientific GmbHDeutschland 1mo Assess regulatory impact of CMC, manufacturing, supply, and labelling changes for clinical trial medicinal products and coordinate implementation across EU/EEA requirements.
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Regulatory Affairs Specialist (m/w/d) SmarAct GmbHRemote 1mo Identify and translate regulatory, normative, and technical developments into actionable requirements for precision positioning and measurement systems in the Life Science & Light Microscopy sector.
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Medical Devices Auditor - Organics. German speaking (m/f/x)↗ Bsi €74k–€90k1mo Conduct audits on medical devices (Organics, Chemistry, Pharma, Human Animal Tissue) to assess quality management systems, support patient safety, and ensure regulatory compliance.
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Medical Writer (m/w/d) Jotec GmbHRemote 1mo Draft, edit, and manage clinical regulatory documents (CERs, CEPs, PMCF plans/reports) and scientific articles for aortic disease medical devices.
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Regulatory Affairs Engineer, Post-Market Surveillance Neko-HealthStockholm 1mo Operate and improve the post-market surveillance (PMS) system across the medical device portfolio, ensuring consistent application of PMS SOPs and generating periodic reports for Notified Bodies.
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Director, Combination Products & Device Development AbCelleraVancouver CA$200k1mo Architect device platform strategy and oversee design controls to advance drug-device combination products (prefilled syringes, autoinjectors) through commercial launch.
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Director, Combination Product Program Lead PraxisprecisionmedicinesRemote $205k1mo Lead the end-to-end development of a novel drug-device combination product pairing proprietary therapeutics with an advanced dermal delivery platform.
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