Back to Job SearchAre you an experienced clinical medical device professional with a strong background in design controls, clinical evidence, and remediation activity?
Our client is a global consultancy operating within the Pharmaceutical and Medical Device sectors, supporting organisations across highly regulated international markets. Due to continued growth and increasing client demand, they are seeking a Clinical SME, Design Controls Remediation to support current and upcoming projects in the USA.
This is a fully remote opportunity for a high-calibre clinical specialist who can bring strong technical expertise and a practical, solutions-focused approach.
The opportunity
In this role, you will play a key part in supporting remediation and design control activities within a medical device environment. You will work closely with cross-functional teams to ensure clinical documentation, evidence strategies, and design inputs are aligned with regulatory and quality expectations.
Key responsibilities
You will be responsible for:
- Conducting gap assessments of clinical study plans, protocols, and data against design control and regulatory requirements
- Supporting the development of clinical evaluation reports, risk-benefit assessments, and post-market clinical follow-up plans
- Aligning clinical evidence with validation protocols and user needs documentation
- Providing robust clinical justification for design changes during remediation projects
- Working collaboratively with pre-clinical specialists and systems engineers to support an integrated evidence strategy
About you
To be successful in this role, you are likely to bring:
- An advanced clinical degree together with strong medical device clinical research experience
- Experience in clinical trials or clinical evaluation within ISO 14155 and FDA regulated environments
- Strong expertise in clinical risk management and clinical evidence generation for regulatory submissions
- Previous involvement in clinical remediation activity, particularly within DHF remediation or pre-market approval projects
- Strong clinical study design, interpretation, and data analysis skills
- Excellent communication skills and the ability to work effectively across multidisciplinary teams in a remote setting
Why apply?
This is an excellent opportunity to join a well-established international consultancy supporting technically complex projects in highly regulated environments. You will have the chance to contribute to meaningful work, collaborate with experienced professionals, and add value across important remediation and compliance programmes.
Recruitment process
If your application is considered a strong match, a member of the recruitment team will contact you to arrange an initial interview.
Following a successful first stage, you will be invited to attend a technical interview with the hiring team.
If feedback is positive, the recruiter will contact you to discuss the next stage of the process or a formal offer. If your application is not being progressed, you will also be informed.
Equality, inclusion and accessibility
Our client is committed to creating an inclusive and supportive recruitment process. Applications are welcomed from all suitably qualified individuals regardless of age, disability, gender identity, marital or civil partnership status, pregnancy or maternity, race, religion or belief, sex, or sexual orientation.
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.
