Field Clinical & Product Specialist (1099 → Full-Time Path)

Amberimplants; United States; Vor Ort; USD 70.000 - 90.000; Teilzeit

Zusammenfassung

Amberimplants is seeking a Field Clinical & Product Specialist to support clinical adoption and commercialization of spinal technologies in the United States. This role will initially be on a contract basis and may evolve into full-time. You will provide on-site clinical support, train physicians, and support clinical trials while managing your own schedule. A Bachelor's degree in biomedical engineering or related field, along with 2–5 years of experience in medical devices, is required.

This position offers a clear growth path into a commercial-facing role, with travel and interaction with healthcare professionals.

Qualifikationen

• 2–5 years of experience in a field clinical role or medical device support.
• Experience supporting surgeries in an operating room environment.
• Familiarity with clinical trials and EDC systems.

Aufgaben

• Provide intraoperative support and training for surgical staff.
• Maintain documentation in accordance with Quality Management System.
• Support product launches and provide technical support.

Kenntnisse

Excellent communication skills

Interpersonal skills with surgeons

Technical aptitude

Attention to detail

Ausbildung

Bachelor’s degree in biomedical engineering or related field

Master’s degree (preferred)

Jobbeschreibung

About the role

We are seeking a highly motivated Field Clinical & Product Specialist to support clinical adoption and commercialization of our innovative spinal technologies.

This role will initially be engaged as an independent contractor (1099). The engagement can evolve into a full-time employment opportunity as the company expands its U.S. footprint, subject to mutual agreement.

During the clinical phase, you will provide on-site clinical support, including procedural support in the operating room (OR), product training for physicians and staff, and support of clinical trial activities in accordance with applicable regulatory and quality requirements. You will collaborate with investigators and clinical sites while operating as an independent field resource.

As we move into commercialization, the engagement may evolves into a product specialist role supporting product launches, training activities, and ongoing clinical and technical support.

This is a field-based role requiring travel and presence in clinical settings. The ideal candidate is entrepreneurial, operates independently, and is comfortable managing their own schedule and priorities while building strong relationships with surgeons, interventional radiologists, and hospital stakeholders.

Key Responsibilities

Clinical Trial Support

• Provide intraoperative support and ensure safe and effective use of the company’s products, including presence in the OR for every surgery as required.
• Train surgeons, fellows, and OR staff on the proper use of the device prior to first use and throughout the trial.
• Act as the field contact for assigned clinical trial sites.
• Support site initiation visits, investigator meetings, and refresher trainings as needed.
• Ensure correct preparation, availability, and use of products, and disposables during procedures.
• Support investigators and site staff with protocol-related questions and procedural workflows.
• Maintain close professional relationships with surgeons, study coordinators, and hospital staff.
• Follow up with surgeons and site personnel regarding study-related inquiries, including questions related to clinical outcomes, device usage, and trial logistics.
• Support investigators and sites in responding to Electronic Data Capture (EDC) queries in a timely and accurate manner.
• Act as a liaison between clinical sites and internal teams (clinical, quality, regulatory, R&D).

Documentation & Quality System Compliance

• Complete and maintain all required documentation in accordance with the company’s Quality Management System (QMS).
• Accurately fill in and submit clinical trial forms
• Ensure compliance with applicable regulations and standards (e.g., ISO 13485, MDR, FDA QSR, GCP as applicable).
• Support audits and inspections by providing field-level documentation and explanations when required.

Cross-Functional Collaboration

• Provide structured feedback from the field to internal teams regarding device performance, usability, and procedural workflows.
• Contribute to continuous improvement of training materials, IFUs, and clinical support tools.
• Support clinical, regulatory, and quality teams with field insights during trial execution.

Transition to Product Specialist Role in long term

• Support product launches by training new customers (surgeons, OR staff, distributors).
• Provide on-site and remote technical support for commercial procedures.
• Assist with proctoring, workshops, and educational events.
• Support post-market clinical follow-up activities and customer feedback collection.
• Represent the company professionally in clinical and commercial settings.

Reporting Line

• Reports to: Clinical Affairs Manager in EU and Commercial Manager in the United States
• Dotted-line collaboration with: Quality, Regulatory Affairs, Sales & Marketing

Qualifications

• Located in the United States of America and willing to travel to different states and if necessary to EU
• Bachelor’s degree in biomedical engineering, life sciences, nursing, or a related field (Master’s degree is a plus).
• 2–5 years of experience in a field clinical role, clinical research, or medical device support (spine, orthopedics, or interventional devices preferred).
• Eligible for hospital OR access and vendor credentialing, including completion of required OR safety, infection control, HIPAA/GDPR, and GCP trainings (e.g. VCS, RepTrax, symplr or equivalent)
• Proven experience supporting surgeries in the operating room environment.
• Familiarity with clinical trials and interaction with investigators and study coordinators.
• Experience with EDC systems and clinical trial documentation (preferred)
• Prior exposure to ISO 13485, MDR, or FDA-regulated environments (preferred)
• Strong clinical and technical aptitude.
• Excellent communication and interpersonal skills, particularly with surgeons and OR staff.
• High level of accuracy and attention to detail in documentation.
• Ability to work independently in the field and manage multiple sites and priorities.
• Comfortable working in high-pressure OR environments.
• Willingness to travel frequently, including early mornings, evenings, and occasional weekends.
• Strong sense of ownership, accountability, and professionalism.

This role offers a clear growth path from clinical trial execution into a commercial-facing product specialist position, with potential future progression into senior clinical, training, or commercial roles within the organization.

About the company

Amber Implants is a fast-growing, clinical-stage medical device start-up specializing in orthopaedics and trauma. Our flagship innovation—the VCFix Spinal System—offers a novel, minimally invasive solution for the treatment of traumatic vertebral fractures.