The Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. This position entails development of FDA submissions, requires working knowledge of products under review and of relevant regulations and guidance documents. This i

Coordinates and prepares document packages for regulatory submissions for new and mature products, ensuring compliance with local and regional registration requirements. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitor

The Production Planner will be responsible for developing and managing the manufacturing schedule across multiple product lines, ensuring supply to the market and minimizing backorders. The individual will work to optimize operations to maximize efficiency and performance within the department. Hours 7 00 am 4 00pm or 8 00 am to 5 00 pm Essential Functions Develops a prod

The Senior Cost Accountant will work closely with the manufacturing facilities to provide meaningful financial data to run the business. The essential functions of this role include the ability to work with the Finance Team as well the manufacturing facilities to determine efficiencies and perform root cause analysis related to production activities. This role will be a k

Our Imaging, Navigation and Robotics Division (INR) has seen tremendous growth, as we continue to bring new and exciting products to market, and set the technology standard with our suite of products. Given this growth, we are recruiting for a motivated, solutions orientated leader to join our team as the Plant Controller at our Methuen, MA location. Reporting to the Sr D

The Patent Paralegal is responsible for supporting the intellectual property attorneys within the Legal Department. This effort includes, but is not limited to, transactional IP work, litigation support and licensing support. This individual will also work with Product Development to ensure innovation is captured and protected. The person must be detail oriented, organize

The Compliance Manager works with the Director of Compliance and Chief Compliance Officer to support our Global business on compliance matters relating to adherence to relevant policies, codes, laws, and regulations impacting business operations. The Compliance Manager will assist with various aspects of our compliance program, including compliance training, auditing and

The Senior Analyst will assist in the analysis, planning and execution of M&A, Corporate Development & Investor Relations initiatives. This is a great opportunity to flex your analytical horsepower and transaction experience to help execute a growing medical device company's strategic plan. As a key member of our dynamic and active Corporate Development team, you will lea

The EDM Wire Operator wires and operates assigned machines to produce parts, all of which must meet the dimensional specifications of the mechanical engineered drawing. This effort includes, but is not limited to, conducting basic machine changeovers, accurately completing quality control documentation and inspection sheet. Assists operators in the diagnosis of part dimen

Our rapidly growing medical robotics division is searching for enthusiastic firmware engineer wanting to make a difference. Our skillful engineers develop medical robots by working with top surgeons and cross functional engineering teams. The Firmware Engineer will be part of electrical team responsible for designing and implementing embedded firmware for surgical robotic

The Mechanical Engineer will work to develop medical robots by working with top surgeons and a cross functional engineering team. The ideal candidate needs to have strong technical skills in mechanical engineering. The position will be hands on, and the individual must be capable of creative and systematic product development with minimum supervision. The position will re

The Pricing Analyst will work in a fast paced, team oriented environment, and will be responsible for all aspects of assigned regional healthcare account pricing. The position will support assigned regional field sales Vice President, Area Directors, and sales representatives, and partner closely with internal departments to support the sales teams by providing accurate a

The Staff Software Engineer will be working on an exciting new Robotics product development project in our Enabling Technology division. This person needs to have strong architectural and technical skills in software engineering and be comfortable as a technical lead for a small group of software engineers on the project. The position will be hands on with the individual

The Senior Group Marketing Manager, Anterior Interbody Fusion (IBF) is responsible for driving the direction of the product portfolio and leading the team to execute on strategic initiatives for growth. This individual provides direction and support of products and applications and is responsible for portions of design, implementation, and maintenance of future products a

The Marketing Manager, Cervical actively participates in downstream marketing activities by supporting global product launches, sales and customer training, customer events, and collateral development. This effort includes, but it not limited to, supporting product development efforts from launch through commercialization, defining market requirements for our product line