Position Name: Business Development Representative

Classification: Full-Time/Salaried

Reports to: Senior Director of Sales & Product Management

Date: October 1, 2023

JOB DESCRIPTION

RIVANNA is seeking a motivated Business Development Representative (BDR) responsible for generating new leads and developing relationships with anesthesiologists and CRNAs (Certified Registered Nurse Anesthetists) to promote and sell Accuro, a medical ultrasound device. The BDR will also be responsible for supporting existing accounts and encouraging the purchase of accessories and consumable supplies used alongside the ultrasound device.

Responsibilities

• Act as an Accuro product expert to maximize implementation, adoption, and outcomes for new and potential Accuro customers.
• Generate new leads through inbound marketing (digital marketing) and outbound activities (emails and phone calls).
• Making effective product presentations remotely and occasionally in person
• Support existing accounts and encourage the purchase of accessories and consumable supplies.
• Collaborating with the distributor sales team, acting as a product specialist
• Conduct product evaluations, trials, and in-services remotely and occasionally in person
• Tracking data related to customer activities and opportunities in CRM.
• The ability to drive a car, travel occasionally, and interact with healthcare providers on-site is required; travel is 10% or less. (Close proximity to a major airport preferred)

Education and Requirements

• Bachelor’s degree in biomedical engineering, business, or a related field.
• 2+ years of sales experience in the medical device industry.
• Understanding of the healthcare industry – experience in anesthesia preferred
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Proficiency in Microsoft Office Suite.

RIVANNA Medical offers the following employee benefits: health insurance, vision and dental, group life, long-term disability, paid time off, and 401(k) with match, and more. We are always looking to complement our existing team with individuals that bring unique perspectives and experiences. This variety of thought and perspective drives innovation and strengthens our ability to create an inclusive team environment where our core values of trust, humility, and dedication are practiced every day.

RIVANNA Medical is committed to providing equal employment opportunities to all employees and applicants without regard to race, ethnicity, religion, color, sex (including childbirth, breast feeding and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age, protected medical condition, genetic information, disability or any other protected status in accordance with all applicable federal, state and local laws. All employees must be able to lift at least 25 pounds. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

About Rivanna Medical, Inc.

RIVANNA® is a privately held designer, manufacturer, and distributor of world-first, imaging-based medical solutions based in Charlottesville, VA. RIVANNA operates an FDA-registered and ISO 13485:2016 certified manufacturing facility where it produces the Accuro® product line and related medical equipment and components. Accuro is the world’s first spinal navigation device designed to improve the safety, speed and efficiency of spinal needle guidance procedures. RIVANNA’s revolutionary platforms feature BoneEnhance®, Multi-Frequency Image Reconstruction, which optimizes ultrasound for the visualization of bony versus soft tissue anatomy, and SpineNav3D™ AI-Based Spine Recognition, which automates ultrasound image interpretation.

Position Name: Sr. Product Manager

Classification: Full-Time/Salaried 

Reports to: Sr. Director of Sales and Product Management 

Date: October 1, 2023

JOB DESCRIPTION

Rivanna Medical, Inc. is seeking a dynamic and highly skilled Product Management professional to contribute to the rapid growth of our emerging medical device company. This position will work within a talented team of professionals as we strive to achieve our mission of elevating the standard of care by leveraging innovative and world-class imaging technology.

A successful candidate must have a strong background in product development and have successfully launched medical devices. Experience in medical imaging and physician marketing in hospitals is desired. The ideal candidate will also have successful experience managing medical device products and enabling sales and marketing efforts that drive adoption. This is a hands-on multidisciplinary role in which the right candidate will engage multiple internal and external stakeholders to develop and execute commercialization plans for both incumbent products and new product launches.

Responsibilities

• Support collaboration between internal R&D, sales, marketing, QA/RA, and manufacturing departments to coordinate commercialization planning and execution
• Support product development planning and execution with R&D, marketing, QA/RA, and manufacturing teams
• Provide mentorship and strategic support to more junior staff
• Support and guide reimbursement strategy and healthcare economics research
• Conduct market research and analyze the competitive landscape
• Lead design reviews and risk assessments to ensure projects stay on track
• Work with clinical affairs and provide hands-on support for our clinical sites during evidence generation activities
• Develop and implement commercialization plans, including strategic positioning, pricing strategy, and brand management
• Collaborate with distribution partners to optimize commercial success
• Stay up to date with industry trends and emerging technologies
• Support commercial excellence for sales and marketing execution
• Travel with sales team(s) and to trade shows and conferences to represent Rivanna Medical
• Collaborate with and enable current and potential distribution partners worldwide.
• Forecast commercial results and augment plans to optimize and outperform forecast.
• KOL Identification, engagement, and development including management of medical advisory committees

Skills and Qualifications

• Bachelor’s degree in engineering, science, or related field. Advanced degree preferred (MS, MBA)
• 5+ years in medical device product development with a focus on upstream development
• Strong leadership skills and experience managing teams
• Medical imaging and physician marketing experience preferred
• Strong analytical and problem-solving skills
• Excellent communication and interpersonal skills
• Ability to work in a dynamic and fast-paced environment
• Strong understanding of FDA and international regulatory requirements
• Experience with project management tools and techniques
• Fluency with Microsoft Office, excellent PowerPoint, and presentation skills

RIVANNA Medical offers the following employee benefits: HSA/FSA health insurance plans, vision and dental insurance, group life, long-term disability, 401(k) match, PTO and more! We are always looking to complement our existing team with individuals that bring unique perspectives and experiences. This variety of thought and perspective drives innovation and strengthens our ability to create an inclusive team environment where our core values of trust, humility, and dedication are practiced every day. 

RIVANNA Medical is committed to providing equal employment opportunities to all employees and applicants without regard to race, ethnicity, religion, color, sex (including childbirth, breast feeding and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age, protected medical condition, genetic information, disability or any other protected status in accordance with all applicable federal, state and local laws. All employees must be able to lift at least 25 pounds. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

About the Company

RIVANNA® is a privately held designer, manufacturer, and distributor of world-first, imaging-based medical solutions based in Charlottesville, VA. RIVANNA operates an FDA-registered and ISO 13485:2016 certified manufacturing facility where it produces the Accuro® product line and related medical equipment and components. Accuro is the world’s first spinal navigation device designed to improve the safety, speed and efficiency of spinal needle guidance procedures. RIVANNA’s revolutionary platforms feature BoneEnhance®, Multi-Frequency Image Reconstruction, which optimizes ultrasound for the visualization of bony versus soft tissue anatomy, and SpineNav3D™ AI-Based Spine Recognition, which automates ultrasound image interpretation

Position Name: Regulatory Project Manager

Classification: Full-Time/Salaried

Reports to: Director of Program Management

Date: August 31, 2023

JOB DESCRIPTION

RIVANNA is seeking a medical device Regulatory Project Manager to contribute to our emerging medical device company’s rapid growth. You will work with a talented team of professionals as we strive to achieve our mission to elevate global standards of care with world-first medical imaging technology. This is a hands-on multidisciplinary role in which the right candidate will actively manage and execute different aspects of RIVANNA’s pre-market regulatory activities and initiatives. The position will report directly to the Director of Program Management and involves frequent written and verbal presentations to Federal government officials. Joining RIVANNA as a Regulatory Project Manager offers an exciting opportunity to make a significant impact on our regulatory success and contribute to the growth of our organization. If you are a highly motivated and detail-oriented regulatory professional with strong project management skills, we encourage you to apply and be part of our dedicated team working towards delivering life-changing products in compliance with regulatory standards.

Responsibilities

• Create, present, and execute premarket regulatory strategies for RIVANNA’s new breakthrough medical device products and R&D programs.
• Coordinate and assist in preparing high-quality regulatory submissions, including premarket notifications 510(k), De Novo approval applications, and post-approval submissions.
• Liaise with cross-functional teams, such as R&D, Quality Assurance/Regulatory Affairs, and clinical teams, to gather necessary documentation and data for submissions.
• Coordinate with external regulatory consultants for premarket regulatory project execution and management.
• Maintain surveillance on long-range and emerging issues related to regulation in the US and internationally.
• Monitor, assess, and provide concise summaries of FDA regulations, guidance, and industry updates relevant to RIVANNA’s product portfolio.
• Communicate regulatory changes and recommendations to internal stakeholders to ensure proactive compliance.
• Organize and maintain project timelines, deliverables, and milestones related to premarket regulatory activities.
• Track project progress, identify potential bottlenecks, and facilitate problem-solving to ensure on-time completion of regulatory milestones in coordination with other stakeholders.
• Maintain accurate and up-to-date records of all premarket regulatory activities, ensuring that documentation is compliant with FDA requirements.
• Generate reports and summaries for management and regulatory authorities as necessary.
• Review and monitor regulatory compliance for clinical studies.
• Assist clinical team with regulatory aspects of clinical study IRB submissions and approvals.
• Responsible for all regulatory aspects of future FDA-regulated study execution.
• Monitor, assess, and provide concise summaries of FDA-regulated medical device clinical trials, 510(k) clearances, De Novo clearances for products close to our product line for competitive analysis.

Education and Requirements

• Advanced degree or bachelor’s degree (required) plus at least five years of regulatory affairs experience or ten years of product development experience as a major contributor to regulatory submissions.
• Demonstrated knowledge of FDA regulations, guidance, and relevant industry standards and procedures and policies related to the conduct of clinical trials/evaluations research.
• Proven experience in preparing FDA submissions and interacting with regulatory agencies.
• Experience with medical devices required, software as a medical device, and/or computer-assisted detection devices preferred.
• Demonstrated experience applying creative solutions to complex issues and problems with an open mind and can-do attitude.
• Excellent oral and written communication skills and interpersonal skills.
• High level of attention to detail and significant experience in project management.
• Ability to work independently and collaboratively in a cross-functional environment.

RIVANNA Medical offers the following employee benefits: health insurance, vision and dental, group life, long-term disability, paid time off, and 401(k) with match, and more. We are always looking to complement our existing team with individuals that bring unique perspectives and experiences. This variety of thought and perspective drives innovation and strengthens our ability to create an inclusive team environment where our core values of trust, humility, and dedication are practiced every day.

RIVANNA Medical is committed to providing equal employment opportunities to all employees and applicants without regard to race, ethnicity, religion, color, sex (including childbirth, breast feeding and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age, protected medical condition, genetic information, disability or any other protected status in accordance with all applicable federal, state and local laws. All employees must be able to lift at least 25 pounds. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

About Rivanna Medical, Inc.

RIVANNA® is a privately held designer, manufacturer, and distributor of world-first, imaging-based medical solutions based in Charlottesville, VA. RIVANNA operates an FDA-registered and ISO 13485:2016 certified manufacturing facility where it produces the Accuro® product line and related medical equipment and components. Accuro is the world’s first spinal navigation device designed to improve the safety, speed and efficiency of spinal needle guidance procedures. RIVANNA’s revolutionary platforms feature BoneEnhance®, Multi-Frequency Image Reconstruction, which optimizes ultrasound for the visualization of bony versus soft tissue anatomy, and SpineNav3D™ AI-Based Spine Recognition, which automates ultrasound image interpretation.