Medical Device Project Coordinator - Regulatory Readiness

IntePros

A global medical device company is seeking a Senior Project Coordinator in the Boston area to support system separation initiatives while coordinating with director-level leadership in Quality, R&D, and Regulatory Affairs. The ideal candidate will have strong organizational abilities, thrive in complex environments, and assist in managing interdependencies across multiple workstreams. Responsibilities include preparing meeting materials, monitoring project updates, and ensuring timely communication between teams. The role requires experience within regulated environments and excellent coordination skills. #J-18808-Ljbffr IntePros

Apply

Vacancy posted 1 day ago

Similar jobs that could be interesting for youBased on the Medical Device Project Coordinator - Regulatory Readiness in Boston, MA vacancy

Project Coordinator
Intepros' valued global medical device client is seeking a Senior Project Coordinator to support critical system separation... ...leadership across Quality, R&D, and Regulatory Affairs, ensuring alignment,... ...dependencies, tracking readiness activities, and supporting the...
Regulatory
Medical device
Local area
Shift work
IntePros
Boston, MA
3 days ago
Senior Manager, GMP Inspection Readiness
...Manager, GMP Inspection Readiness Role Responsibilities... ...& gene therapies, medical devices). Develop, implement,... ...readiness plans aligned with regulatory filings, site... ...execution standards. Use project management tools to... ...follow‑up (readiness coordination, logistics/onsite...
Regulatory
Medical device
Scorpion Therapeutics
Boston, MA
3 days ago
Quality Inspection Readiness Manager
...quality drugs, biologics, and medical devices. For more information,... ...Responsibilities Real-time Inspection Readiness Develop, manage and... ...Readiness Plans associated with regulatory filings and real-time... ...inspection readiness Develop project management plans with key metrics...
Regulatory
Medical device
Work experience placement
ELIQUENT Life Sciences
Boston, MA
2 days ago
Project Manager (Medical Devices III)
$90 - $130 per hour
...Job Title Project Manager (Medical Devices III) Position Type Contract Location Contract Salary $9... ...verification and validation, manufacturing readiness, and regulatory submission activities. The... ...PMA design control deliverables. Coordinate validation activities including...
Regulatory
Medical device
Contract work
Ipro Networks Pte. Ltd.
Cambridge, MA
3 days ago
Embedded Systems / Firmware Engineer
...developing innovative wearable devices that improve human health and... ...flows Support manufacturing readiness (DFM, testing procedures,... ...Have Experience with wearables, medical, or sleep tech devices Knowledge... ..., certification, or regulatory exposure (FCC, CE) What We Offer...
Regulatory
Medical device
Full time
Contract work
Nocturnal
Cambridge, MA
3 days ago
Business Development Executive
...leading organization in the medical device manufacturing space is... ...Verification & Validation (V&V) Coordinate internal and customer-... ...ramp-up Ensure readiness across manufacturing, quality... ...quality systems, and FDA/ISO regulatory environments Preferred...
Regulatory
Medical device
Tethered Talent
Boston, MA
3 days ago
Manufacturing quality engineering
...We've partnered with a rapidly growing medical device manufacturing organization looking to hire... ..., equipment validation, inspection readiness, and documentation activities including... ...and documentation meet internal quality, regulatory, and customer requirements Quality...
Regulatory
Medical device
Rbw Consulting
Boston, MA
3 days ago
Business Development Manager - Life Sciences Translation Services
...Services Location: Boston preferred (or Remote) Ready to help medtech companies scale globally with... ...translation. We support global leaders in medical device, biotech, pharmaceutical, and clinical research with regulatory‑grade translation, software localization, and...
Regulatory
Medical device
Remote work
Sesen
Boston, MA
2 days ago
Quality & Regulatory / Post-Market Surveillance
...is critical in ensuring patient safety, regulatory compliance, and effective risk... ...CAPA, and risk files. Maintain audit-ready records. Requirements: ~ Bachelor'... ...field. ~515 years of experience in: ~ Medical device risk management & CAPA. ~ HHE / product...
Regulatory
Medical device
Katalyst Healthcares & Life Sciences
Boston, MA
3 days ago
Head of Engineering
...innovative wearable devices that improve human... ...Execution & Project Management Oversee... ...hardware solutions Coordinate cross‑functional collaboration... ...in health tech, medical devices, or... ...companies Knowledge of regulatory requirements for... ...vision insurance Ready to Transform Sleep...
Regulatory
Medical device
Nocturnal
Cambridge, MA
3 days ago
Clinical Program Specialist
$102k - $162k
...operations, helps keep projects on track, and... ...vendor management, and coordinates across cross‑functional... ...including IT, Clinical/Medical, Regulatory, Legal, Quality, Procurement... ...and training readiness, and support a collaborative... ...within medical device, pharma, biotech, or...
Regulatory
Medical device
Work at office
Relocation package
3 days per week
Council Of State and Territorial Epidemiologists
Cambridge, MA
3 days ago
Head of Project Management (Remote)
...OVERVIEW We are seeking a Project Manager with 4–9... ...capabilities, and experience coordinating cross-functional... ...requirements, and regulatory expectations. WORK LOCATION... ...processes, audit readiness activities, and... ..., pharmaceutical, or medical device. Experience leading physical...
Regulatory
Medical device
Work at office
Remote work
Work visa
Flexible hours
Initial Therapeutics, Inc.
Cambridge, MA
3 days ago
Pharmacovigilance Compliance and Oversight Manager
$130k - $180k
...supporting inspection readiness, CAPA management,... ...teams. While strategic regulatory engagement is led by... ...verification, and closure. Coordinates audit and inspection... ..., biotechnology, or medical device industry.... ...organizational, analytical, and project management skills...
Regulatory
Medical device
Contract work
Temporary work
Work experience placement
Local area
Shift work
Dormont Manufacturing Company
Boston, MA
2 days ago
Manager, Clinical Science, Medical Affairs
$150k - $170k
...Bring more to life. Are you ready to accelerate your potential... ...Manager, Clinical Science, Medical Affairs is a critical strategic... ...the scientific credibility, regulatory compliance and clinical relevance... ...years experience in Medical Device/Pharma/IVD companies ~...
Regulatory
Medical device
Remote work
Work from home
Flexible hours
Danaher Corporation
Boston, MA
6 days ago
Mechanical Design Engineer
...years' experience. Must have medical device experience, disposables... ...wear multiple "hats". Be ready to participate in quality systems... ...engineering, manufacturing, regulatory activities, etc.... ...starter who handles multiple projects at the same time. Willing...
Regulatory
Medical device
Worldwide
Flexible hours
Nanobiosym
Cambridge, MA
26 days ago
Principal Consultant
$64.4k
...partnering with biotech, pharmaceutical, and medical device organizations across the U.S. We... ...Clinical Development, Medical Affairs, Regulatory Affairs, Biometrics, and Commercial functions... ...in the life sciences space who is ready to step into a more strategic, leadership...
Regulatory
Medical device
Permanent employment
Contract work
Work at office
Flexible hours
Hays Recruitment
Boston, MA
5 days ago
Sr. Mgr., Regulatory Affairs (RA) & Clinical Affairs (Evident MIS)
...Key Responsibilities Regulatory Affairs (U.S. Focus)... ...lead for clinical and medical device products, overseeing... ...Maintain inspection readiness and ensure data integrity... ...Collaboration Lead coordination between Clinical... ...EU MDR/IVDR. Strong project leadership and stakeholder...
Regulatory
Medical device
Remote work
Evident Microscopy
Needham Heights, MA
5 days ago
Senior Supervisor, Quality
...(DPC) team by supervising, coordinating, assigning and directing the... ...and records to ensure role readiness and compliance. Partner... ...adherence to quality system, regulatory and safety policies and... ...5 years' experience in the medical device or pharmaceutical industry...
Regulatory
Medical device
Work at office
Local area
3 days per week
Intracept by Boston Scientific
Boston, MA
1 day ago
Central Supply Processing Inventory Tech II
$23.34 - $33.37 per hour
...teams drive groundbreaking medical discoveries and invite all... ...resource for reusable medical device inventory, tracking system... ...accuracy, operational readiness, and regulatory compliance. Essential Functions... ...-related processes. Coordinates complex instrument repair activities...
Regulatory
Medical device
Hourly pay
Remote work
Shift work
Mass General Brigham
Boston, MA
2 days ago
Senior Regulatory Affairs Manager, Medical Devices
...A medical device company in Cambridge, MA, is seeking a Regulatory Affairs professional to lead regulatory strategies for Class II medical devices. Responsibilities include managing FDA submissions, ensuring regulatory compliance throughout product development, and collaborating...
Regulatory
Medical device
Medella Life
Cambridge, MA
2 days ago
Clinical Program Specialist
$102k - $162k
...operations, helps keep projects on track, and... ...vendor management, and coordinates across cross‑functional... ...including IT, Clinical/Medical, Regulatory, Legal, Quality, Procurement... ...and training readiness, and support a collaborative... ...within medical device, pharma, biotech, or...
Regulatory
Medical device
Full time
Work at office
Immediate start
Work visa
Relocation package
3 days per week
Philips North America
Cambridge, MA
2 days ago
Director, Clinical Operations
$210k - $230k
...with a particular focus on Software as a Medical Device (SaMD). You will own operational... ...concept and feasibility through validation, regulatory submission, launch, and post-market evidence... ..., and Trial Master File inspection readiness. Ensure studies are conducted in...
Regulatory
Medical device
Full time
Work at office
Remote work
Relocation
WHOOP
Boston, MA
2 days ago
Remote Systems Engineer - Medical Device Hardware
...is looking for a System Engineer in Boston to enhance their EEG device systems in alignment with precision medicine goals. This role... ...ample experience in managing complex systems, risk analysis, and regulatory requirements in a fast-paced environment. Strong problem-...
Regulatory
Medical device
Remote job
Beaconbiosignals
Boston, MA
5 days ago
Senior Security Engineer
$130k - $170k
...a rapidly growing, Boston-based medical technology company using AI to help... ...regulated Software as a Medical Device (SaMD) environment. You'll work... ..., AWS hardening and audit readiness. You will translate complex security and regulatory requirements into practical controls...
Regulatory
Medical device
Work at office
Remote work
Flexible hours
eLucid
Boston, MA
3 days ago
Staff Electrical Engineer
...We Are: Resonant Link Medical is pioneering the future... ...implantable medical devices to help people get well... ..., manufacturable, and ready for customer delivery.... ...safety standards and regulatory requirements (IEC 6060... ...manage multiple concurrent projects Team‑First Mentality:...
Regulatory
Medical device
Relocation
Stanford Climate Ventures
Cambridge, MA
4 days ago
Vice President of Regulatory Affairs
...Vice President of Regulatory Affairs About the Company A pioneering medical device company developing first-in-class technologies for critical unmet clinical needs. Industry Medical Devices Type Privately Held About the Role The Company...
Regulatory
Medical device
Confidential
Boston, MA
1 day ago
Head of Drug Product Analytical Operations
...strategy for drug products, medical devices, and combination products (methods... ...for development, global regulatory submissions, clinical bulk... ...process validation; launch readiness; commercial transfer). Experience... ...standards. Skills Strong project management/organization;...
Regulatory
Medical device
Scorpion Therapeutics
Boston, MA
4 days ago
Remote Senior Regulatory Affairs Specialist Medical Devices
...Cardinal Health is looking for a Sr Regulatory Affairs Specialist to join their Medical Solutions Regulatory Affairs team. This remote position is responsible... ...compliance across a diverse portfolio of medical devices, including new product development and change assessment...
Regulatory
Medical device
Remote work
Cardinal Health
Boston, MA
5 days ago
Software Quality Assurance Senior Manager
$170k - $210k
...responsible for ensuring the safety, reliability, and regulatory compliance of software used in medical device systems. This role oversees verification and... ...engineering, regulatory, and business teams to deliver audit-ready software solutions used in clinical environments....
Regulatory
Medical device
Hourly pay
Work at office
Flexible hours
Nova Biomedical
Watertown, MA
5 days ago
Associate Director, Corporate Compliance - Operations
$145.5k - $205k
...addressing operational and regulatory challenges with thoughtful,... ...overseeing enhancements and release readiness, and ensuring that processes... ...industry (pharmaceutical, medical device or biotech) or, ~ Master's... ...area expert ~ Strong project/program management experience...
Regulatory
Medical device
Work at office
Remote work
United Therapeutics
Boston, MA
4 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Medical Device Project Coordinator - Regulatory Readiness. Be the first to apply!