Remote Senior Regulatory Affairs Lead, Medical Devices
SOLVENTUM
- Remote job
Solventum, a health care innovator, seeks a Senior Regulatory Affairs Specialist to lead a team supporting Restorative Healing Technologies and drive global product approvals. You will develop regulatory pathways, align strategies with business goals, and ensure lifecycle compliance. Responsibilities include preparing submissions (510(k), EU MDR), guiding regulatory activities, and coordinating with internal and contract partners to meet milestones. Remote US work available. #J-18808-Ljbffr SOLVENTUM
- Solventum is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities for the Restorative Healing Technologies portfolio. Remote work is available in the United States with... ...in regulatory affairs within medical devices, plus experience with ISO 13485,...Remote jobSeniorMedical device
- Solventum is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities for Restorative Healing Technologies on a global scale. This remote US role emphasizes building regulatory strategy, coordinating cross-functional teams, and ensuring compliance from...Remote workSeniorMedical deviceContract work
$109k - $174.8k
...merit. Job Function: Regulatory Affairs Group Job Sub Function... ...States of America, Remote (US) Job Description:... ...the best talent for a Senior Regulatory Affairs Program Lead to support our Wound Closure... ...and currently marketed medical devices. He/she guides...Remote workSeniorMedical deviceFull timeLocal areaImmediate start- ...diabetes care, seeks a Principal Regulatory Affairs Specialist to guide medical devices and software through US FDA, EU MDR... ...other global pathways. You will lead regulatory strategies, interact... ...and international teams. This 100% remote role offers collaboration across...Remote jobSeniorMedical device
- OrganOx Limited is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions... ...and electromechanical devices. The role requires collaborating... ...with ISO, GMP, and medical device standards. The position offers flexible remote or hybrid on-site work in...Remote jobSeniorMedical deviceFlexible hours
- Solventum is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategy and drive timely product... ...requires extensive experience in medical device regulatory submissions (510(k),... ...audits (ISO 13485, MDSAP), with remote/work-from-home flexibility #J-18...Remote jobSeniorMedical deviceWork from home
- ...Reference26-00910Remote50% Remote Job Description Key Responsibilities · Lead FDA audit and... ...interface for FDA inspections, regulatory meetings, and... ...with Quality, Regulatory Affairs, Manufacturing, Engineering... ...industries such as Pharma, Medical Devices, Biotechnology, or...Remote workSeniorMedical device
$140 per hour
...Job Title: Senior Teamcenter PLM Solution Architect & Discovery Lead Location: Remote within the United States, with approximately 40 hours of onsite discovery engagement... ...: We're partnering with a leading medical device company on a long-term PLM transformation...Remote workSeniorMedical deviceHourly payLong term contractFull timePart timeLocal area$125k - $201.25k
...Job Function: Regulatory Affairs Group Job Sub... ...Posting Locations: Remote (US) Santa Clara... ...talent for a Senior Regulatory Affairs Program Lead to support our OTTAVA... ...electromechanical devices with software... ...affairs experience in medical devices including...Remote workSeniorMedical deviceFull timeLocal areaImmediate startFlexible hours$141k - $261.8k
...GCP), Products (Drug and/or Medical Devices), Pharma affiliates, and... ...are seeking an experienced Senior Quality Lead to join the Quality... ...discussions with Legal and Regulatory Affairs.PDQ Goals and Initiatives:... ...is preferred, however, a remote option is a possibility.)Relocation...Remote workSeniorMedical deviceLocal areaRelocation package- ...requirements. The role combines on-site leadership at our Chaska, MN headquarters with remote work flexibility, reporting to the VP of Operations, QARA, and Customer Service. A strong background in medical device quality is essential. #J-18808-Ljbffr IMRIS Imaging, Inc DBA IMRISRemote workSeniorMedical device
- ...development, the full-time Senior Regulatory Affairs Specialist will prepare and... ...cross-functional teams in a remote setting, preferably from... ...development and compliance Lead process improvement initiatives... ...regulatory experience in medical devices or pharmaceuticals Strong...Remote workSeniorMedical deviceFull time
- ...Leading regulatory support for product development teams, the full-time Senior Regulatory Specialist will prepare regulatory... ...regulations in a remote setting. Key... ...regulatory specialist in the medical device or pharmaceutical... ...regulations Regulatory Affairs Certification (RAC)...Remote workSeniorMedical deviceFull time
- Abbott Laboratories seeks a Senior Regulatory Affairs Specialist for Lingo in Alameda, CA. You will support regulatory activities for Class II software medical devices, collaborating with product teams to ensure compliant submissions and labeling throughout development...SeniorMedical device
- LHH is seeking a Senior Regulatory Affairs Specialist in Dublin, California to support global regulatory strategies for medical devices. The role involves preparing submissions, leading communications with regulatory agencies, and ensuring compliance with evolving regulations...SeniorMedical device
- Viltis is seeking a Senior Regulatory Affairs Specialist to support a leading medical device organization in San Diego, CA. The ideal candidate brings 7+ years of Medical Device Regulatory Affairs experience, with strong expertise in regulatory change assessments and U...SeniorMedical device
- Arcetyp LLC is seeking a Senior DoD Regulatory Affairs Specialist - Medical Products for an onsite role in Fort Detrick, MD. You will develop and review regulatory... ...for drugs, biologics, blood products, and medical devices, and prepare or review INDs, NDAs, PMAs, 510(k)s,...SeniorMedical device
- Arcetyp LLC is seeking a Senior DoD Regulatory Affairs Specialist - Medical Products for an onsite role in Fort Detrick, MD. The position focuses on regulatory... ...drugs, biologics, blood products, and medical devices, with responsibilities including IND/NDAs/PMAs/510(k...SeniorMedical device
$220k - $290k
...in people's lives. Our medical devices, software and related services... ....Job SummaryThe Senior Director, Chief Privacy Lead (CPL) serves as the enterprise... ...across Legal, Regulatory Affairs, IT, Cybersecurity, R&D,... ...position is filled. For fully remote positions, compensation...Remote workSeniorMedical deviceMinimum wageOngoing contractFull timePrivate practiceLocal areaWorldwide- Abbott Laboratories seeks a Senior Regulatory Affairs Manager for Digital Solutions, on-site in Sylmar, CA or Santa Clara, CA. You will lead regulatory submissions and guide cross-functional... ...FDA and EU pathways for SaMD and medical devices. The role requires 9+ years in...SeniorMedical device
- Innovative Health LLC is seeking a Sr. Regulatory Affairs Specialist to prepare and submit documentation for FDA 510(k)s and Canadian applications... ...candidate will have at least 8 years of experience in the Medical Device industry and a Bachelor's Degree in Life Science, with...SeniorMedical device
- Shifamed is seeking an experienced Regulatory Affairs Lead to oversee US, EU and Japan submissions for a class III medical device within Supira Medical’s portfolio. The role requires strategic planning, writing and submission management for IDE, PMA, EU Design Dossiers...SeniorMedical deviceWork at office
- AtriCure, Inc. in Minnesota seeks a Senior Regulatory Affairs Specialist to originate documents to obtain and maintain marketing privileges worldwide... ...other international filings. The role serves as regulatory lead on development projects, supports post-market changes, and...SeniorMedical deviceWorldwide
- A leading medical device company is seeking a Regulatory Affairs Specialist to develop and execute strategies for medical devices, including wearable technology. The role requires 8-10 years of experience in US and EU regulatory affairs and strong project management skills...Remote jobMedical deviceFull time
- A leading medical device company is seeking a Medical Writer Specialist to prepare regulatory documents and conduct scientific writing. This role demands a Ph.D/Pharm D or an equivalent... ...is based in Raynham, MA, with options for remote work for experienced professionals. #J-188...Remote jobSeniorMedical deviceWork at office
- ...of the largest global medical technology companies... ...outstanding chance for a Senior Regulatory Affairs Specialist to join a... ...marketing medical devices internationally. This... ...cross-functional teams, lead the creation of... ...and work-life balance. Remote or field-based positions...Remote workSeniorMedical deviceFull timeWork at officeWorldwide
- ...pharmaceutical, biotech, and medical device organizations to address complex regulatory and operational... ..., and regulatory affairs, supporting... ...experienced Consultant or Senior Consultant with a... ...Responsibilities Lead and deliver client... ...preferred Fully remote role Occasional...Remote workSeniorMedical deviceFull time
$100.32k - $125.4k
...Hybrid (3 days onsite) Senior Specialist, Regulatory AffairsAdvanced... ...Specialist, Regulatory Affairs to develop and... ...experience with Class III medical devices, PMA submissions,... ...engineering activities.Lead end-to-end... ...required to support any remote/hybrid employee functionality...Remote workSeniorMedical deviceTemporary workWork at officeFlexible hours- Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist to support Ethicon Wound Closure & Healing products. You will guide global regulatory... .... Preference is given to candidates near Raritan, NJ, with remote work options considered on a case-by-case basis. This role...Remote jobSenior
$156.8k - $261.3k
...Department is seeking a Lead Counsel,... ...managing legal and regulatory risk. The role reports... ...partner to senior Human Resources, Finance... ...Audit, Regulatory Affairs, and business operations... ..., pharmaceutical, medical device, healthcare... ...Richmond; USA, GA, Remote; USA, FL, RemoteType...Remote workMedical deviceFull time
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