Senior Regulatory Affairs Specialist Job at Katalyst Healthcares and Life Sciences, Westminster, CO

V25tQUltN25yT3duVkJFUmsrRWQzN2R3
  • Katalyst Healthcares and Life Sciences
  • Westminster, CO

Job Description

Responsibilities: Prepare and submit regulatory documentation for domestic and international markets, ensuring compliance with applicable regulations (i.e. PMA, HDE, 510ks, letters to file, and Tech Docs). Provide regulatory direction to development project teams as a core team member. Develop regulatory strategy for new products, evaluating risk of proposed strategies and offering solutions. Review proposed labelling for compliance with applicable global regulations. Review proposed product changes for impact on regulatory status of the products. Contribute to the development and maintenance of Instructions for Use and Surgical Technique Guides. Review and evaluate promotion and advertising material for compliance with applicable regulations. Communicate with regulatory and governmental agencies. May provide training and/or guidance to entry-level associates, analysts, interns, and specialists. Support additional regulatory compliance items as required by regulations and as needed by the RA team. May provide training and/or guidance to entry-level associates, analysts, interns, and specialists. Requirements: Bachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred.

  • Preferred) Minimum of 2 years of experience in orthopaedic or medical device industry.
  • Required) A minimum of 5-7 years of experience in Regulatory Affairs, Engineering, Quality, or related field.
Combination of education and experience may be considered. Skills: Strong writing, communication, and interpersonal skills. Strong attention to detail. ble to multi-task and balance competing priorities, and willingness to work with changing priorities. Knowledge of overall business environment, ideally within the orthopaedic industry. Eager to build relationships between Regulatory Affairs and other teams within the organization. bility to communicate effectively at all levels. dvanced knowledge of FDA, EU, and other regulatory body regulations. Katalyst Healthcares and Life Sciences

Job Tags

Similar Jobs

West Virginia Staffing

Part-Time Truck Unloader (Required 6am Start) Job at West Virginia Staffing

 ...Required Early Morning Availability About the Role: In this role, you will deliver excellent customer service and consistent execution of store operations. You will efficiently process freight, replenishment, and omni channel operations. What You'll Do: Receive... 

ABM Industries

Valet Parking Attendant Job at ABM Industries

 ...Details: The Valet provides professional, courteous and compassionate guest services. Should be available to work at Kent and/or Sussex...  ...hourly range or the hourly rate for this position. A specific o Parking Attendant, Valet, Attendant, Parking, Hotel, Property Management... 

Reach Dane

Human Resources Manager Job at Reach Dane

 ...evaluating HR policies, programs, and practices Supervising and directing two Human Resources Generalists Maintaining and enhancing the HR department's effectiveness and service delivery Managing talent acquisition, recruitment, and onboarding processes Handling... 

Westchester Medical Center

HOSPITAL CARE AIDE (SITTER) Job at Westchester Medical Center

 ...Job Summary ~ A Hospital Care Aide (Sitter) is a paraprofessional employee, trained to provide supervision, companionship, environmental...  ...support assistance. Reports changes in condition of patient and any safety issues to unit staff immediately. Population served... 

DSV A/S

Freight Forwarder, Ocean Import Job at DSV A/S

 ...local and close to our customers. Read more at Location: Phoenix, AZ Division: Air & Sea US Job Posting Title: Freight Forwarder, Ocean Import Time Type: Full Time Duties and Responsibilities Manage the importation of goods by ocean,...