There are three current employment opportunities at ThermaSolutions
Business Development Manager (Europe)
Regulatory Affairs Specialist (US)
Service Technician/Technologist – Biomedical (Europe)
Business Development Manager – Europe
ThermaSolutions Europe B.V. | Remote | International Travel Required
About ThermaSolutions
ThermaSolutions is a global leader in hyperthermic medical technology, advancing treatment options for oncology patients through research, development, and product innovation. We manufacture and distribute the ThermoChem™ HT-2000 and the broader ThermoChem™ HT family of systems and disposables, used to deliver Hyperthermic Intraperitoneal Chemotherapy (HIPEC) as an adjunct to cytoreductive surgery for ovarian, gastric, appendiceal, and colorectal cancers. We also manufacture the HurriChem™, a single-use device used to aerosolize liquids for delivery into body cavities during laparoscopic and other minimally invasive surgeries. The device consists of a wand and high-pressure tubing.
Since the early 2000s, ThermoChem™ HT systems have been adopted by more than 100 leading oncology centers across the USA, Europe, the Middle East, and Asia. We support our distributors and physicians through direct sales, service, and support in the U.S., alongside a well-established international distribution network. ThermaSolutions is a private company headquartered in St. Paul, Minnesota, and offers a collaborative environment where individuals matter. Learn more at thermasolutions.com.
About the Role
We are looking for a Business Development Manager to grow new accounts across Europe. You’ll work with distributors and oncology surgeons whose patients benefit from HIPEC administered in the operating room, helping expand ThermaSolutions’ presence and impact across the region.
Responsibilities
- Identify and develop new markets, channels, and partnerships among oncology centers, hospital systems, and distributors
- Find, onboard, and train distributors and surgical teams
- Represent and market ThermaSolutions throughout the region
- Manage key accounts and build relationships with existing and prospective clients
- Conduct market analysis and prepare business plans to guide strategic growth
- Coordinate with regional distributors and support pricing and contract negotiations
- Collaborate with internal marketing, regulatory, and operations teams
- Monitor performance against sales targets and provide regular reporting and forecasts
- Represent the company at international conferences, trade shows, and customer meetings
- Support other regional activities as needed
Qualifications
- Bachelor’s degree or higher
- Prior operating room experience, ideally with oncology procedures (ovarian, gastric, appendiceal, or colorectal cancers); operating room sales experience a plus
- Familiarity with hospital credentialing requirements and working knowledge of anatomy
- Proven track record in international business development, with experience expanding markets and building global partnerships
- Experience in international sales and account management, including distributor networks and key hospital/oncology accounts
- Strong business planning skills — market analysis, sales forecasting, strategic growth planning
- Excellent communication, negotiation, and presentation skills across cultures and time zones
- Strong analytical and problem-solving skills; comfort with CRM tools and standard business software (Excel, PowerPoint)
- Self-motivated, organized, and able to work independently in a remote role while collaborating cross-functionally
- Multilingual ability is a plus
- Willingness to travel throughout Europe
Regulatory Affairs Specialist
ThermaSolutions, United States
About ThermaSolutions
ThermaSolutions is a global leader in hyperthermia medical technology and is seeking an exceptional candidate to join our organization.
ThermaSolutions (TS) develops and manufactures medical devices used in the surgical treatment of ovarian, gastric, appendiceal and colorectal cancers. Our company works with clinicians at the leading cancer-treatment centers throughout the world. TS has manufacturing of medical devices on three continents, and operates from our European office (Netherlands) and our headquarters location in the Twin Cities in Minnesota.
TS presents an opportunity to work in a collaborative environment where individuals matter. A benefits package includes health insurance, holidays & paid time off, continuing education, 401K retirement plan, mobile telephone plan and a hybrid onsite/offsite work location.
The Role
The Regulatory Affairs Specialist will play a key role in supporting regulatory strategy and compliance throughout the product lifecycle. Reporting to the Global Product Director, this individual will partner closely with Engineering, Quality, Operations, Manufacturing, and external regulatory consultants to support both commercial products and new product development.
This position will focus heavily on FDA and EU MDR regulatory activities while supporting multiple new product launches over the coming years. The successful candidate will also mentor a junior Regulatory Affairs Specialist and help develop future regulatory talent through internship programs as the organization continues to grow.
Expectations:
Working with your regulatory and quality team members, you will:
- Develop and execute regulatory strategies supporting Class II medical devices throughout the product lifecycle.
- Prepare, maintain, and submit FDA 510(k) regulatory submissions and support international registrations as needed.
- Lead EU MDR compliance activities, including maintenance of Technical Documentation, Essential Requirements Checklists, and Declarations of Conformity.
- Maintain knowledge of evolving FDA, EU MDR, and other global regulatory requirements to ensure ongoing compliance.
- Serve as the Regulatory Affairs representative on cross-functional product development teams supporting three active new product development programs.
- Review engineering change orders and assess regulatory impact for product and process changes.
- Maintain compliance with existing regulatory submissions and determine appropriate regulatory pathways for product modifications.
- Develop and maintain regulatory procedures and documentation supporting the Quality Management System.
- Partner with external regulatory consultants, Notified Bodies, and regulatory agencies as needed.
- Support regulatory inspections, audits, and agency interactions to ensure successful outcomes.
- Collaborate with Quality, Engineering, Manufacturing, and Product Development teams to successfully commercialize new products.
- Mentor and develop a junior Regulatory Affairs Specialist while helping build future regulatory talent through internship programs.
- Balance thorough regulatory analysis with timely execution to keep projects moving while maintaining compliance.
Requirements:
- Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or a related field.
- Minimum of three years of Regulatory Affairs experience within the medical device industry.
- Strong knowledge of FDA regulations, including experience supporting or preparing 510(k) submissions.
- Working knowledge of EU MDR requirements and CE Technical Documentation.
- Experience supporting Class II medical devices throughout development and commercialization.
- Understanding of Design Controls, engineering change processes, and regulatory impact assessments.
- Excellent organizational, communication, and cross-functional collaboration skills.
- Ability to manage multiple priorities while maintaining attention to detail and meeting project timelines.
- Medical device manufacturing experience preferred.
- Candidates should be comfortable using Microsoft Office programs and possess excellent interpersonal skills.
- Candidate shall be able to operate a motor vehicle and travel domestically and internationally as needed.
ThermaSolutions is a private company with headquarters located in the suburbs of St Paul, MN. Visit our web site at www.thermasolutions.com for more information.
Service Technician/Technologist – Biomedical
ThermaSolutions Europe B.V. | International Travel Required
About ThermaSolutions
ThermaSolutions, LLC, (TS) is a global leader in hyperthermia medical technology and is seeking an exceptional candidate to fill the position of Service Technician or Service Technologist; based out of the Breda, Netherlands office.
This role will be responsible for:
- Providing technical support via telephone and online directly to both customers and sales personnel.
- Work will be performed at TS Breda office, customer hospitals and clinics across Europe, and as-required to locations abroad.
- Performing technician level tasks on our medical devices including: preventive maintenance, safety testing, performance verification in accordance with manufacturer specifications and regulatory requirements.
- Maintaining accurate service records, field reports, and compliance documentation for each site visit.
- Providing field feedback to the engineering department for design issues, failure modes, and improvement opportunities.
- Assisting with documentation of technical procedures, work instructions, and service bulletins.
- Receiving, inspecting and preparing devices for shipment to customer locations.
This is a hands-on, cross functional role combining technical field service with logistics, purchasing support, product assembly, and engineering collaboration. The ideal candidate is a mobile, detail-oriented field technician comfortable working independently in clinical environments while supporting broader operational functions. This role will work directly with the TS support staff as well as field sales associates in Europe.
Minimum Qualifications:
- 2+ years’ experience working in a Biomedical Technician or Technologist role.
- Ability and willingness to travel within Europe and occasionally abroad.
- Strong communication skills in English (written and spoken).
- Experience with Microsoft Office suite of programs.
- Comfortable interacting with hospital and clinic personnel while on service calls.
- Comfortable interacting with external customers and end-users via telephone and email.
- Must possess the ability to occasionally lift up to 40 lbs. Physical fitness for operating in an office and hospital environment.
Preferred Qualifications
- Membership with professional organizations VZI, BMTZ or similar.
- Strong electrical and mechanical aptitude with testing and repairing experience.
- Working knowledge reading/interpreting electrical & mechanical drawings, schematics, and technical manuals.
- Multi-lingual: Dutch language preferred.
- Qualified and licensed to operate a motor vehicle.