Senior Medical Device Project Manager PMA & Regulatory Lead
The Fountain Group
The Fountain Group is seeking an experienced Project Manager (Consultant) in Boston to lead the development and regulatory submission of Class III long-term implantable medical devices. This position requires strong expertise in FDA submissions and management of cross-functional teams. Ideal candidates should have a Bachelor's degree and 7–12+ years of experience in medical device programs. The role also offers opportunities for remote work for exceptional candidates. #J-18808-Ljbffr The Fountain Group
$212k - $333.19k
...worldwide. About the role As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device... ...and life‑cycle management with a focus on Human... ...Reviews and approves medical device development design... ...GRA with GRLs, CMC RA project leads and other GRA sub...SeniorMedical deviceFull timeTemporary workLocal areaWorldwideNight shift$160k - $180k
Jobot is seeking a Sales Manager to join their fully remote team, focusing on sales within the injection molding sector. The ideal... ...record in sales and business development, particularly with medical device OEMs. You will develop effective business strategies, collaborate...SeniorMedical deviceRemote job- ...in Boston is seeking a Principal R&D Project Manager to lead projects within the Navigation... ...projects while ensuring compliance with regulatory standards. The ideal candidate will... ...regulated environments, particularly in medical devices or robotics. This position offers a...SeniorMedical device
- A healthcare technology company is seeking a Sr. Regulatory Affairs Specialist in Somerville, Massachusetts, to support the commercialization of its digital products and AI technologies. The role involves providing regulatory input on product development, maintaining compliance...SeniorMedical deviceRemote job
$122.25k - $176.58k
**Job Title:** Senior Manager, Regulatory Affairs Advertising and Promotion... ...as regulatory lead for product launches.... ...defense, and development projects. Serve as the primary... ...) for commercial and medical materials,... ...pharmaceutical or medical device advertising and promotional...SeniorMedical deviceWork experience placement- ...149-DePuy Synthes Products Inc. is seeking a Principal R&D Project Manager to oversee the Navigation platform within Digital R&D. The... ...budget management, ensuring compliance within a regulated medical device environment. The ideal candidate should have a Bachelor’s degree...SeniorMedical device
- Johnson & Johnson is seeking a Senior Navigation Systems Software Manager in Boston, MA. You will lead an embedded software team focused on innovative surgical navigation... ...development experience and a background in medical devices. This hybrid role involves collaboration...SeniorMedical device
- ...hematologic, and other complex diseases. As Manager Regulatory Lead you will be accountable for... ...as the regulatory lead for one or more projects and coordinates the Global Regulatory... ...employees may be eligible to participate in medical, dental, vision insurance, a 401(k)...SeniorMinimum wageOdd jobFull timeTemporary workLocal areaFlexible hours
- ...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...SeniorMedical device
$110k - $125k
...Technologies, Inc. is looking for a Senior Clinical Research Associate... .... This role involves data management, clinical operations, and ensuring compliance with regulatory standards. The candidate... ...research, preferably within the medical device or pharmaceutical industry. The...SeniorMedical deviceRemote job- ...strategic and experienced Senior Regulatory Consultant -... ...stakeholders including Medical Affairs, Legal, Commercial... ...accurate communications Lead discussions on risk... ..., biotech, or medical device industry, with a strong... ...influence, and stakeholder management skills Strong...SeniorMedical device
- Insight Global in Boston, MA is seeking a Senior Project Manager to lead and deliver project management services across a portfolio of commercial real estate assets. You'll manage multiple small projects in a fast-paced environment, requiring strong ownership and adaptability...Senior
$270k - $330k
...Position Overview The Senior Director, Global Regulatory Affairs, Oncology is... ...considerations. Lead regulatory consultation... .... Proven experience managing complex worldwide products or projects in a relevant... ...Knowledge Knowledge of medical device/drug device combination...SeniorMedical deviceTemporary workWorldwideFlexible hours- Kemper is looking for a Senior Scrum Master who will be instrumental in enhancing Agile processes across teams. You will lead Agile executions and coach teams to achieve high performance... ...with Product Owners and Project Managers to streamline project deliveries and...SeniorRemote job
$212k - $333.19k
...worldwide. Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you... ...guidance, and lead late-stage projects to ensure innovative and... ...stakeholders and senior management. Acts independently under... ...to participate in medical, dental, vision insurance...SeniorMinimum wageTemporary workLocal areaWorldwide$270k - $330k
...The Senior Director, Global Regulatory Affairs, Oncology is accountable... ...assigned products and projects and serving as the... ...where appropriate, and leads operational... ...project team and senior management decision making.Be... ...preferred):Knowledge of medical device / drug device...SeniorMedical deviceTemporary workLocal areaWorldwideFlexible hours$208.2k - $327.14k
A leading global R&D organization is seeking a Senior Director, Global Regulatory Lead - Oncology. This role involves leading global regulatory strategy and engaging with cross-functional teams to ensure the success of innovative oncology therapies. The successful candidate...Senior$137k - $215.27k
...MA, to contribute to Global Regulatory Affairs CMC. The role requires... ...+ years of regulatory CMC or Device experience and a BS/BA degree... ...executing regulatory strategies and managing submissions. The position... ...benefits including medical, dental, vision insurance, and...Senior- Takeda is seeking a Senior Director, Global Regulatory Lead for Oncology in Boston, MA. This role involves leading global regulatory strategy for complex oncology projects, with responsibilities that include overseeing FDA submissions and ensuring compliance with regulatory...Senior
$137k - $215.27k
Takeda is seeking a Regulatory Affairs professional in Boston, MA to lead regulatory CMC initiatives for various pharmaceutical products. The role requires a... ...strong foundation in scientific principles. You will manage regulatory submissions and foster relationships with...Senior$120k - $160k
A leading engineering solutions provider is looking for a Senior Project Manager specializing in Hazardous Building Materials and Industrial Hygiene in Boston, MA. The role involves developing client relationships, managing environmental compliance projects, and mentoring...Senior- Responsibilities Lead development and implementation of regulatory strategies for pure device and drug-device combination products with a focus on Human Factors across... ...registration, commercialization, and lifecycle management. Maintain and communicate CMC/quality...SeniorNight shift
$120k - $150k
A medical device company in Massachusetts seeks a Regulatory Affairs lead dedicated to clinical and medical device products. This role involves overseeing FDA submissions and managing clinical studies. Candidates should have 7-10 years of experience in Clinical Affairs...SeniorMedical deviceRemote job- ...Project Manager - Medical Device Software Waltham, MA Role Summary We are seeking a seasoned Project Manager with extensive experience in the medical... ...Orders to manage scope effectively. Agile & Team Leadership: Lead Agile/Scrum ceremonies, including daily stand-ups and...SeniorMedical device
- ...Massachusetts is seeking a Senior Quality Engineer to enhance... ...compliance. This role involves managing quality initiatives and... ...teams to ensure adherence to regulatory standards. The ideal candidate... ...years of experience in the medical device industry, demonstrate strong...SeniorMedical device
$90 - $130 per hour
...Job Title Project Manager (Medical Devices III) Position Type Contract Location Contract... ..., and Premarket Approval (PMA) submission of a Class III... ...manufacturing readiness, and regulatory submission activities. The... ...timelines. Responsibilities Lead integrated project plans...Medical deviceContract work- ...Location: Somerville, MA Senior Mechanical Engineer – Medical Device Overview: Micro-Leads is a fast-paced early-stage company... ...Identify, source, and manage vendors to obtain hardware components... ...system, understands essential regulatory requirements, and follows...SeniorMedical deviceContract work
- ...Massachusetts Job Description - Senior Lead Counsel Procurement and Contracts (Program Manager Specialist IX) (260003J0)... ...with applicable statutory and regulatory requirements. Lead MassDOT’s and... ...coordinating transportation policies and projects for the Commonwealth of...SeniorFull timeContract workPart timeFor contractorsShift work
$110k - $188.75k
We’re looking for a seasoned Project Manager to drive high‑visibility initiatives in AML compliance... ...skills, with direct exposure to senior leadership.What you will be responsible... ...insurance coverage including basic life, medical, dental, vision, long-term disability,...SeniorContract workTemporary workFlexible hours- Insite US, a leading public accounting firm in Boston MA, is seeking an experienced International Tax Supervisor. This role focuses on managing client engagements and overseeing tax compliance for international, federal, and multi-state returns. The ideal candidate should...Senior
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