Medical Device Quality Systems Expert
4 days ago
We are seeking a highly skilled Medical Device Quality Systems Expert to join our team at RQMIS Inc. Based in the north of Boston, Massachusetts area, we provide strategic guidance to companies navigating FDA, UK, and EU regulations.
About the RoleThe ideal candidate will have a strong background in medical device and combination product regulations, with experience in software quality system design and management. As a Regulatory Compliance Specialist - Software Development, you will assist clients in ensuring compliance with relevant regulations, including GMPs, QSR, ISO 9001, and IEC 62304.
This is a full-time position that offers a competitive salary of $120,000 per annum, based on industry standards and location. You will also enjoy a comprehensive benefits package, including health insurance, retirement plan, and paid time off.
Responsibilities- Assist clients in implementing software quality systems that meet regulatory requirements.
- Audit client quality systems to ensure compliance with FDA's QSR, ISO 13485, and other regulations.
- Develop and implement tools for employees to conduct their activities efficiently.
- Design and implement IQ/OQ/PQ for client equipment and processes.
- Bachelor's degree in computer science, engineering, or a scientific field.
- 6-10 years' experience in drug, biologics, tissue regulations, and standards.
- Strong attention to detail, computer skills, and leadership abilities.
The work environment is moderate noise level, with occasional travel required. The company offers a dynamic and fast-growing environment with opportunities for professional growth.
-
Boston, Massachusetts, United States Best Buy Health Full timeAbout the RoleWe are seeking an experienced Global Medical Devices Regulatory Compliance Expert to join our team at Best Buy Health. In this role, you will be responsible for ensuring the global regulatory compliance of medical devices throughout their lifecycle, from development to post-market surveillance.Key Responsibilities:Develop and implement...
-
Medical Device Consultant Lead
4 weeks ago
Boston, Massachusetts, United States Eurofins USA Medical Devices Full timeDrive impactful client outcomes and shape the future of consulting services for Eurofins USA Medical Devices.About the RoleWe are seeking a seasoned professional to lead our consulting business, building a strategic vision and team to support clients in the medical device industry across their product innovation, regulatory compliance, and quality assurance...
-
Boston, Massachusetts, United States Medical device manufacturer has unique products and huge demand Full time**Job Description**As a Sales Professional for Medical Device Territory, you will be responsible for selling directly to a broad and growing customer base inclusive of Hospitals and Ambulatory Surgery Centers.Our client is a recognized global leader in medical products used in the Operating Room, and they are looking for an accomplished sales professional to...
-
Senior Sales Specialist
2 days ago
Boston, Massachusetts, United States Medical device manufacturer has unique products and huge demand Full timeJob Overview:Our client, a global leader in medical products used in the Operating Room, is seeking a Sales Specialist to join their team in the greater Boston area. As a key member of the sales team, you will be responsible for selling directly to hospitals and ambulatory surgery centers, driving sales growth and expanding our market presence.The successful...
-
Boston, Massachusetts, United States Takeda Pharmaceutical Full timeJoin Takeda Pharmaceutical as a Senior Regulatory Expert for Device and Combination Product Development. We are seeking an experienced professional to lead the development and implementation of innovative device and integral/co-packaged combination product regulatory strategies in the US.About the Role:Takeda is a forward-looking, world-class R&D...
-
Regulatory Expert
3 weeks ago
Boston, Massachusetts, United States Takeda Pharmaceutical Full timeAbout the RoleAt Takeda Pharmaceutical, we are a world-class R&D organization dedicated to unlocking innovation and delivering transformative therapies to patients worldwide. Our forward-thinking approach enables us to push the boundaries of what is possible in the field of pharmaceuticals.We are seeking a highly skilled Regulatory Expert - Device and...
-
Medical Device Compliance Manager
4 days ago
Boston, Massachusetts, United States Jobot Full timeJobot is a well-established consulting firm providing solutions to medical device companies, pharmaceuticals, and biologics. We are seeking a Medical Device Compliance Manager to join our team.About the CompanyAt Jobot, we pride ourselves on being a dynamic and forward-thinking organization that values innovation and excellence.As a Medical Device Compliance...
-
Toxicology Risk Expert for Medical Devices
4 weeks ago
Boston, Massachusetts, United States Gradient Full timeJob TitleSenior Medical Device Toxicologist - Job OverviewCompany OverviewGradient, a Geosyntec Company, is an environmental and health risk sciences consulting firm specializing in environmental sciences, human and ecological risk sciences, product stewardship, and life sciences. Our scientists have diverse backgrounds in chemistry, engineering, toxicology,...
-
Medical Device Sales Executive
3 weeks ago
Boston, Massachusetts, United States Greenlight Guru Full timeUnlock Growth with Our Medical Device Sales TeamAre you a sales professional looking for a new challenge? Do you have a passion for the medical device industry? We're seeking an experienced Sales Account Executive to join our team in Atlanta or Boston.We empower innovative medical device companies to bring life-changing products to market faster. Our leading...
-
Senior Quality Assurance Engineer
2 days ago
Boston, Massachusetts, United States RQMIS Inc Full timeAbout the RoleWe are seeking a skilled Senior Quality Assurance Engineer to join our team at RQMIS Inc, a leading medical device and biotechnology consultancy. As a key member of our team, you will be responsible for providing expert guidance on quality system design and management, ensuring compliance with regulatory requirements.The ideal candidate will...
-
Boston, Massachusetts, United States Takeda Pharmaceutical Full timeCompany Overview">Takeda Pharmaceutical is a forward-thinking, world-class R&D organization that drives innovation and delivers transformative therapies to patients worldwide. By focusing R&D efforts on key therapeutic areas, we push the boundaries of what is possible to bring life-changing treatments to patients globally."> ">Job Summary">We are seeking a...
-
Boston, Massachusetts, United States Takeda Pharmaceutical Full timeCompany OverviewTakeda Pharmaceutical is a forward-thinking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients worldwide.Job DescriptionWe are seeking a highly skilled Regulatory Advisor to join our team in the US. This role will be responsible for developing and implementing innovative device and...
-
Medical Device Innovation Specialist
1 week ago
Boston, Massachusetts, United States Unreal Gigs Full timeUnlock the future of medical technology with Unreal Gigs as a Medical Device Innovation Specialist. As a key player in our team, you will design and develop cutting-edge medical devices and technologies that transform patient care and healthcare outcomes. Your expertise in biomedical engineering will enable you to integrate engineering principles with...
-
Principal Design Engineer
3 weeks ago
Boston, Massachusetts, United States WeCare Medical Specialty Group Full timeWe are seeking a highly skilled Principal Design Engineer to join our team at WeCare Medical Specialty Group. This role will be responsible for the development of next-generation medical devices.About UsAt WeCare Medical Specialty Group, we are committed to improving patient outcomes through innovative medical technology and design. Our team of engineers,...
-
Boston, Massachusetts, United States Top Tier Reps LLC Full timeAbout the RoleAs a Sales Representative Medical Devices Professional at Top Tier Reps LLC, you will have the opportunity to work with a variety of medical devices and build strong relationships with healthcare professionals. Our company values professionalism, integrity, and teamwork, and we are looking for someone who shares these values.Salary:...
-
Quality Systems Engineer
2 days ago
Boston, Massachusetts, United States Connexion Systems & Engineering, Inc. Full timeQuality Systems EngineerWe are seeking a talented Quality Systems Engineer to join our team at Connexion Systems & Engineering, Inc. in Boston.The successful candidate will be responsible for promoting MTO and QA-aligned compliance best practices to further establish operational and quality event record center of excellence teams.This is a full-time position...
-
Boston, Massachusetts, United States Expert Healthcare Full timeHome Health Occupational Therapist OpportunityWe are seeking a compassionate and experienced Home Health Occupational Therapist to join our team at Expert Healthcare. In this vital role, you will provide individualized therapy services in patients' homes, helping them regain their independence and improve their quality of life after injury, surgery, or...
-
Medical Devices Territory Executive
4 weeks ago
Boston, Massachusetts, United States Bestlogic Staffing Full timeLead Territory Expansion in East Coast Medical DevicesWe are seeking a seasoned Territory Executive to spearhead our growth strategy in the East Coast medical devices market.This role is ideal for an experienced sales leader with a proven track record of driving revenue growth and expanding client relationships. The successful candidate will lead a...
-
Medical Device Territory Manager
2 weeks ago
Boston, Massachusetts, United States Top Tier Reps LLC Full timeJob DescriptionWe are seeking a highly motivated and results-driven Medical Device Territory Manager to join our team at Top Tier Reps LLC. This is an exceptional opportunity for a skilled sales professional to maximize their earning potential while building strong relationships with medical professionals.Salary: Commission-based with a performance bonus,...
-
Medical Device Sales Professional
1 day ago
Boston, Massachusetts, United States SalesForce4Hire Full timeJob DescriptionWe are seeking a highly motivated Medical Device Sales Professional to join our team at SalesForce4Hire. As a key member of our sales team, you will be responsible for selling medical devices in the Endoscopic Sinus Surgery market.Salary: $80,000 - $120,000 per year (dependent on experience)In this role, you will work closely with physicians...