- Create and manage comprehensive product/project databases
- Develop and execute strategic product line release plan(s)
- Work closely with Regulatory lead/Quality team, keeping stakeholders updated
- Liaise across departments for regulatory documentation (domestic & international)
- Manage clinical/non-clinical stakeholders for product release readiness
- Maintain, improve and update all relevant regulatory documentation/best practices
- Participate in CAPA Review Board, recommending corrective actions
- Assist with regulatory information management system, QMSR processes, new eQMS
- 7+ years of Quality/Regulatory Affairs experience in Medical Device industry
- Regulatory Affairs knowledge
- Quality Management system knowledge
- 510K submissions
- Clinical submissions and trials
- MDR (Medical Device Rugulation/Reporting)
- ISO
- EU requirements
- MDSAP (Medical Device Single Audit Program)
- Auditing experience
-
Dotnet Project Manager
4 weeks ago
Rapid Eagle Inc Boston, United StatesJob DescriptionJob DescriptionDotnet Project Manager · Onsite interview · Baltimore MD · Skills :- · 7+ Years in C# · 7+ Years experience into .Net Development · ASP.NET · Typescript, Angular · Infrastructure exposure · Excellent communication skills · ...
-
Project manager H/F
3 weeks ago
Linkfinance Boston, United StatesNew · 04 April · District de Luxembourg, Luxemburg · Perm · Premier gérant d'actifs européen parmi les 10 premiers acteurs mondiaux [1], Amundi propose à ses 100 millions de clients - particuliers, institutionnels et entreprises - une gamme complète de solutions d'épargne et d ...
-
IT Project Manager
1 week ago
Softworld, a Kelly Company Boston, United StatesIT Project Manager (Banking Ops) · Remote from East coast · Contract · Job Description · Project Manager with experience working with hybrid agile/waterfall teams. Experience working with Scrum teams, project planning, forecasting, coordination among workstreams. Ability to eff ...
-
Project Manager
3 days ago
Dexian - DISYS Boston, United StatesExceptional ability to manage multiple concurrent projects and priorities. · Project portfolio or program management experience is a plus. · Executive level reporting and communications skills · Risk management to properly identify risks on time, propose strategies, workaround, a ...
-
Project Manager
3 weeks ago
Scienta Boston, United StatesLocation Boston · About the company · Our client is a Cell & Gene Therapy Biotech organization based in Boston. They are looking for an experienced Operations Manager/Project manager to join them in order to enhance and develop their project efficiency. · Key Responsibilities ...
-
Project Manager
1 week ago
Centizen, Inc. Boston, United StatesJob Description: · GT Title: Project Management - Lead New Title; The nature of the work is focused on defining tools and processes to support overall organizational excellence in program/project management and process definition. Manages projects with a duration of typically 12 ...
-
Project Manager
3 weeks ago
Hexaware Technologies Boston, United StatesWhat Working at Hexaware offers: · Hexaware is a dynamic and innovative IT organization committed to delivering cutting-edge solutions to our clients worldwide. We pride ourselves on fostering a collaborative and inclusive work environment where every team member is valued and em ...
-
Project Manager
1 week ago
Langton Howarth Boston, United StatesFixed Term Contract 18-24 months TBA · WFH Boston Massachusetts with travel between sites to conclude the pharmaceutical plant relocation project. · Do you have successful site relocation project management experience of shutting down and relocating a major Laboratory facility or ...
-
Project Manager
3 weeks ago
Agile Talent Consulting Boston, United StatesTHE OPPORTUNITY · TribalVision is seeking a Project Manager to successfully manage all client projects through their lifecycle, including scoping proposals and timelines, creating estimates, as well as managing budgets and work-back schedules. The PM role is responsible for being ...
-
IT Project Manager
2 weeks ago
Selby Jennings Boston, United StatesThe top quantitative asset management firm in Boston is looking to hire a new IT Project Manager to their team · Responsibilities: · Scope, plan, and execute mid to large scale IT projects including implementing new systems, modernizing cloud applications, and administering a new ...
-
Project Manager
2 weeks ago
V-Soft Consulting Group, Inc. Boston, United StatesPosition: Project Manager (Non-IT) · Location: Boston, MA (On-site) · Duration: 6+ months · Position Overview: · Job Description: · This Lead Project Manager will be focused on defining tools and processes to support overall organizational excellence in program/project management ...
-
Project Manager
1 week ago
Beacon Hill Boston, United StatesProject Manager to 130K · Our client, a fast-paced general contracting and design firm, is looking for an experienced Project Manager to join their Boston office In this role, you will be responsible for planning, executing, and closing-out projects based upon deadlines and budg ...
-
Project Manager
3 weeks ago
Vanderweil Engineers Boston, United StatesAbout US · Vanderweil Engineers was founded in 1950 and is a top ranked national full-service engineering firm specializing in MEP/FP and technology services. Working in multiple sectors including Science & Technology, Mission Critical, Academic, Healthcare and Commercial buildin ...
-
Project Manager
2 weeks ago
DBI Projects Boston, United StatesPosition: Project Manager · Position Description: · DBI Projects is seeking to bring on a Project Manager capable of managing capital projects across all stages. DBI values an individual who has the ability and drive to work hard, who is highly motivated, and who is not afraid to ...
-
Project Manager
3 weeks ago
Medasource Boston, United StatesPosition: Project Manager (Research Informatics, Research Administration, Research Computing) · Location: Boston, MA - remote · Duration: 12 months · Job Description: · Our client is looking to bring on a project manager to help support the various projects an initiatives amongst ...
-
Project Manager
2 weeks ago
Digital Prospectors Boston, United StatesPosition: Project Manager · Location: Boston, MA (Remote, Part-Time – 1 to 2 days a week) · Length: 6+ months · Job Description: · Our client is currently looking for a Part-Time Project Manager who will drive implementation excellence and efficiency by managing operational tasks ...
-
Project Manager
3 weeks ago
Webby Central Boston, United StatesLocation: Boston / Walpole, MA | Opening: 1 Position | Experience: 3+ Years · Summary : · We're AppsChopper ), a DBA of Webby Central LLC. · We are hiring a client champion for the role of project or account manager capable of pre-sales, creating wireframes, crafting proposals, a ...
-
Project Manager
3 weeks ago
Hexaware Technologies Boston, United StatesAbout Hexaware: · Hexaware Technologies is the fastest growing organization of today, Hexaware gives you great growth prospects, the opportunity to work along with brilliant minds, and a diverse range of high-profile clients, as well as an ideal work-life balance with 37 global o ...
-
Project Manager
3 weeks ago
Smith & Wilkinson Boston, United StatesBeals Associates is a respected and well-established civil engineering and planning firm that provides services to the real estate development industry. They're seeking an experienced civil engineer to work as a Project Manager in their Boston office. The job responsibilities inc ...
-
Project Manager
3 weeks ago
Russell Tobin Boston, United States· What are we looking for in our Project Manager? · Title: Project Manager · Contract: 8 months with strong possibility of extension · Location: Boston, MA (remote) · Pay-range: $90-$100/hour on W2 (Depending on Experience) · Job Description: · Coordinate site-cut over ope ...
Regulatory Project Manager - Boston, United States - Gabriele & Company
Description
Job Title: Regulatory Project Manager
Gabriele & Company, recruiters for manufacturing and supply chain professionals, is assisting a globally renowned, small medical device company whose products are used in nearly half of all hospitals in the US. This world leader in their market niche is seeking an exceptional Regulatory Project Manager to drive new product line initiatives.
Reporting to the VP, you will spearhead the management of new product line(s). In this pivotal role, you will collaborate cross-functionally to ensure products seamlessly align with technical, regulatory, clinical, and market standards.
Salary Range: $120,000 - $150,000 per year, commensurate with experience, along with a generous benefits package.
Key Responsibilities:
Requirements:
Bachelor's degree
Please apply or reach out if interested in this Quality and Regulatory Project Manager opportunity with a global medical device leader