Quality/Regulatory Affairs Manager
- Experience Level
- Experienced (non-manager)
(Main purpose of the job) This position is responsible for supporting the activities of the Design Owning Organization at the company's UK facility. The candidate will work with the Elstree Product Design Owner (PDO) in performing tasks related to regulatory compliance, change control, design control, and risk management for Advanced Surgery products produced under the Elstree DOO.
Essential Duties and Responsibilities
(List of primary responsibilities of this role that account for 5% or more of the work. Incumbent may perform other duties as assigned.)
Support the PDO in fulfilling requirements for regulatory compliance, design control and risk management activities for Orthobiologic products manufactured at Elstree
Lead activities required in the design and development assurance and documentation to maintain regulatory compliance, particularly for the new European Medical Device Regulation (MDR).
Review and execute regulatory gap assessments against existing and new Regulation.
Maintain and remediate Design History Files and Risk Management files for Elstree products
Generate and manage work flow for appropriate change control documentation.
Project management of projects related to design assurance, risk management and DHF remediation.
Support the PDO in gathering information from Subject Matter Experts (SMEs) and technical resources for complaint investigations, change control, and regulatory submissions
Other tasks as needed
(To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.)
* Solid communication skills - both written and oral
* Organizational skills and attention to detail
* Ability to work effectively independently and in team environment.
* Experience working in regulated industry (medical devices, drugs, biologics) is preferred.
* Knowledge and experience working with medical device regulatory requirements, design control, change control, and risk management is highly desirable.
Education and/or Experience * Bachelor's degree in a scientific or engineering discipline with 1-5 years' work experience or MS with 0-2 years' experience