Back to Job SearchROLE OVERVIEW
We are currently looking for a Regulatory Affairs Specialist – Design Controls Remediation to join a leading medical device company operating remotely across the US. This exciting opportunity is ideal for a professional eager to contribute their regulatory expertise to ensure compliance and support remediation activities within a dynamic and innovative environment.
As part of our client's team, you will play a pivotal role in maintaining the integrity of design control documentation and supporting regulatory submissions, ensuring alignment with global standards and expectations.
KEY DUTIES AND RESPONSIBILITIES
Your duties as the Regulatory Affairs Specialist – Design Controls Remediation will be varied however the key duties and responsibilities are as follows:
• Provide regulatory oversight and subject matter expertise across design controls remediation activities, ensuring alignment with global regulatory requirements and expectations.
• Review design control documentation across the product lifecycle, including User Needs, Design Inputs and Outputs, Design Verification and Validation, and Design Transfer.
• Assess the regulatory impact of remediation activities, including documentation updates, design changes, and potential submission implications.
• Support the development, revision, and maintenance of regulatory documentation, including inputs to submissions, technical files, and design dossiers, as required.
• As the Regulatory Affairs Specialist, you will ensure that all activities meet pertinent regulatory standards and contribute to successful product lifecycle management.
ROLE REQUIREMENTS
To be successful in your application to this exciting role as the Regulatory Affairs Specialist – Design Controls Remediation we are looking to identify the following on your profile and past history:
• A Degree or higher level in a scientific or engineering discipline.
• Proven industry experience in Regulatory Affairs within the medical device sector, with exposure to design controls and lifecycle documentation.
• A working knowledge and practical experience with global regulatory frameworks, including FDA (21 CFR Part 820/Part 807), EU MDR, and other applicable regulations.
WHAT’S IN IT FOR YOU?
This role offers the opportunity to work remotely with a leading client in the medical device industry, providing exposure to global regulatory standards and the chance to make a meaningful impact on product compliance and lifecycle management. You will also join a committed team that values innovation and professional growth.
Key Words: Regulatory Affairs / Design Controls / Remediation / Medical Device / DHF / FDA / EU MDR / 510(k) / PMA / Technical Files / Design Dossiers
“Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.”
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
