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 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 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 lab manager role is a full time position responsible for the efficient management and coordination of the day to day operations of the laboratory. The role requires a strong understanding of laboratory processes and protocols, excellent communication, meticulous attention to detail and commitment to safety. The role will be based out of Audubon, PA. Essential Function

The Associate 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. The Model Maker will also be responsible for maintenance of the machines including calibration,

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 Associate Product Manager will be responsible for supporting the product development team with a wide range of marketing activities. This position will also be the primary liaison between each product development group and sales personnel. The ideal candidate will have strong self starting ability to independently manage multiple projects to ensure timely completion o

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

The Laser Marking Operator is responsible for the setting up and operating the CNC laser equipment to produce finished goods within the Implants/Trauma department. This effort includes, but is not limited to, reading drawings and work instructions. This individual works with the entire department to ensure all finished materials are laser marked correctly and up to compan

The ideal candidate is a self starter, detail orientated, and able to work in a fast paced environment with the ability to multi task. Strong communication skills, dependability, flexibility and a willingness to learn and grow are important qualities to succeed in the role. The Tax Manager will be a key player in our day to day tax function, working directly with the Dire