Waltham, Massachusetts, United States · Hybrid
$109k–$183k/yr
PURPOSE AND SCOPE: Develops regulatory strategies for assigned products/product lines. Prepares regulatory submissions required to market new or modified medical devices in the domestic and international clinical markets…
Skills: Regulatory strategy, Medical device regulations, FDA submissions, 510(k) submissions, PMA submissions
Waltham, Massachusetts, United States · On-site
$22/hr–$29/hr
When you join the growing BILH team, you're not just taking a job, you’re making a difference in people’s lives. Reports to: Practice Manager or Ambulatory Practice Coordinator with input from assigned physician(s), nurs…
Skills: Phlebotomy, EKG, Injections, Vitals collection, Patient communication
Lawrence, Massachusetts, United States · Hybrid
$148k–$246k/yr
Hybrid: Upon agreement between you and your supervisor, you are entitled to a flexible arrangement where you will be able to split your time between working from the Lawrence, MA or Waltham, MA office and working remotel…
Skills: Strategic leadership, Compliance program management, Risk assessment, Policy development, Regulatory compliance
Waltham, Massachusetts, United States · Remote OK
$193k–$275k/yr
Work Schedule Standard Office Hours (40/wk) Environmental Conditions Office Job Description Senior Director, Commercial Operations Position Summary The Senior Director, Commercial Operations will lead the advancement of …
Skills: Commercial operations, Sales force effectiveness, Strategic planning, Data-driven decision making, Predictive analytics
Waltham, Massachusetts, United States · On-site
Pyramid Global Hospitality is a leading hospitality management company with a portfolio of more than 200 hotels and resorts and over 18,000 associates across the United States, Caribbean, and Europe. Our platform include…
Skills: Maintenance, HVAC, Electrical repairs, Plumbing, Carpentry
Waltham, Massachusetts, United States · Remote OK
Responsibilities: • Drives sales results to achieve / exceed specific sales volume, revenue, and profitability targets. • Deliver flu portfolio product sales in key accounts including Pediatrics, IDN, FQHCs, independent/…
Skills: Pharmaceutical Sales, B2B Sales, Account Management, Strategic Planning, Communication Skills
Waltham, Massachusetts, United States · On-site
$142k–$185k/yr
CareDx is a leading precision medicine diagnostics company advancing care in transplant, specialty oncology, and cell therapy. Through our innovative portfolio of molecular diagnostics, digital health solutions, AI-power…
Skills: Clinical laboratory operations, Molecular diagnostics, CLIA compliance, Regulatory leadership, Quality assurance
Waltham, Massachusetts, United States · On-site
$15/hr–$17/hr
Join Our Team as a Retail Sales Representative! Are you ready to dive into the fast-paced world of wireless technology and make a real impact? Join us as a Retail Sales Representative and become the energetic, friendly f…
Skills: Retail sales, Customer service, Communication, Wireless technology, Sales promotion
Waltham, Massachusetts, United States · On-site
$15/hr–$17/hr
Join Our Team as a Retail Sales Representative! Are you ready to dive into the fast-paced world of wireless technology and make a real impact? Join us as a Retail Sales Representative and become the energetic, friendly f…
Skills: Customer Service, Sales, Communication, Retail Sales, Device Troubleshooting
Waltham, Massachusetts, United States · On-site
$30/hr–$62/hr
Join Our Team as a Retail Sales Manager – Lead the Future of Wireless Technology! Are you ready to lead the charge in the exciting world of wireless technology? Join us as a Retail Sales Manager and become the driv…
Skills: Team leadership, Sales management, Staff training, Performance coaching, Customer engagement
Waltham, Massachusetts, United States · Hybrid
$26/hr
We are seeking a Pharmacy Adjudication Specialist at our Specialty pharmacy in Waltham, MA. This will be a Full-Time position. This position must be located within driving distance to our pharmacy, with a hybrid work sty…
Skills: Pharmacy claims adjudication, NDC medication billing, Pharmacy claims resolution, PBM contracts, Medical contracts
Waltham, Massachusetts, United States · Remote OK
Join our team at Onco360 as Intake/Prescription Setup Pharmacy Technician for our Specialty Pharmacy located in Waltham, MA. Are you looking for a change working in a great pharmacy environment? Looking for skilled candi…
Skills: Pharmacy terminology, Sig codes, Roman numerals, Data entry, Customer service
Waltham, Massachusetts, United States · On-site
$142k–$236k/yr
Work Flexibility: Onsite We are looking for a seasoned Program Manager in our Peripheral Vascular Division who thrives as an individual contributor while operating confidently in highly cross‑functional, regulated enviro…
Skills: Program Management, PMO, Project Management, Medical Devices, Risk Management
Waltham, Massachusetts, United States · On-site
$15/hr–$24/hr
Click here to see - A Day in the Life - Deli Clerk A Day in the Life: As a Deli Clerk, no one day is ever the same. You are someone who prides themselves on exceptional customer service and their knowledge of deli meats,…
Skills: Customer service, Food preparation, Meat slicing, Cheese slicing, Food safety
Waltham, Massachusetts, United States · On-site
$15/hr–$24/hr
A Day in the Life: As a Baker, no one day is ever the same. To truly be successful in the position, you will be passionate about baking breads, cookies, and pastries, as well as producing fancy desserts and decorating ca…
Skills: Baking, Bread making, Pastry preparation, Cake decorating, Customer service
Waltham, Massachusetts, United States · On-site
$15/hr–$18/hr
Click here to see - A Day in the Life - In Store Shopper A Day in the Life: As the In-Store Shopper you will have the opportunity to be the best and select “the best of the best” for our online shoppers. To be successful…
Skills: Customer service, Product selection, Teamwork, Fast-paced environment, Attention to detail
Waltham, Massachusetts, United States · On-site
$15/hr–$18/hr
A Day in the Life: When you begin your job with us working on the front-end as a courtesy clerk, customer service associate, or cashier, you are taking a step towards an opportunity that can help you learn, grow, and eve…
Skills: Customer Service, Communication, Interpersonal Skills, Cashiering, Retail Operations
Forsyth, Georgia, United States · On-site
Requisition ID: 180179 Job Level: Mid Level Home District/Group: TIC Power District Department: Field Operations Market: Power Employment Type: Full Time Position Overview The Electrical Lead Field Engineer is responsibl…
Skills: Electrical engineering, Power distribution, Commissioning, Construction management, Technical troubleshooting
Waltham, Massachusetts, United States · On-site
$15/hr–$27/hr
Location: Bentley University We are hiring immediately for full time and part time GRILL COOK positions. Address: 175 Forest Street, Waltham, MA 02452. Note: online applications accepted only. Schedule: Full time and par…
Skills: Grill Cooking, Food Preparation, Customer Service, Food Safety, Portion Control
Waltham, Massachusetts, United States · On-site
$15/hr–$25/hr
Location: Bentley University We are hiring immediately for full time and part time CASHIER positions. Address: 175 Forest Street, Waltham, MA 02452. Note: online applications accepted only. Schedule: Full time and part t…
Skills: Cash Handling, Customer Service, Point Of Sale (POS), Cash Reporting, Sanitation Standards
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Develops regulatory strategies and prepares submissions for medical devices to ensure compliance with domestic and international requirements. Manages assigned projects, provides regulatory guidance to development teams, and oversees the approval of engineering and promotional documentation.
Requires a Bachelor's degree and at least 8 years of related experience, with specific expertise in 510(k) submissions. Candidates must demonstrate strong knowledge of medical device regulations and the ability to manage complex projects independently.
Develops regulatory strategies for assigned products/product lines. Prepares regulatory submissions required to market new or modified medical devices in the domestic and international clinical markets. Develops and maintains procedures and systems designed to ensure the product development process addresses all regulatory requirements as well as the objectives of the business.
The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
10 – 15% domestic and international travel as required.
Annual Rate: $109000 - $183000
Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave and potential for performance-based bonuses depending on company and individual performance."
Fresenius Medical Care is the world’s leading provider of products and services for individuals with renal diseases. We aim to create a future worth living for chronically and critically ill patients – worldwide and every day. Thanks to our decades of experience in dialysis, our innovative research and our value-based care approach, we can help them to enjoy the very best quality of life. Our portfolio encompasses a comprehensive range of high-quality health care products and services as well as various dialysis treatment options for both in-center and home dialysis that are individually tailored to our patients’ needs.
Offices: Else-Kröner-Strasse 1, Bad Homburg, Frankfurt 61352, DE
