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

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

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

The Marketing Manager, Anterior Interbody Fusion (IBF) 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 requiremen

The Model Maker is responsible for prototype fabrication to support product development. This includes bringing a product from idea/concept through design, prototyping, development, testing, design verification and validation, manufacturing, and product introduction. This individual will also be responsible for maintenance of the machines including calibration, regularly

The Group Manager, US Regulatory, is responsible for preparing, filing and gaining approval of 510(k), IDE, and PMA submissions to the U.S. Food and Drug Administration (FDA) for class II and class III products. This position entails management of submissions to the FDA, requiring working knowledge of products under review and of relevant regulations and guidance document

The Lead Regulatory Affairs Specialist leads the preparation of document packages for regulatory submissions for new and sustaining enhanced technologies, software enabling and robotics systems within the Surgical Intelligence (SI) portfolio, to ensure compliance with local and regional registration requirements. The Lead Specialist will be responsible for coordinating pr

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