Clinical Research Scientist

Össur•Irvine, CA

2d•Onsite

About The Position

As a Clinical Research Scientist, you will be part of a team that plays a critical role in the creation and maintenance of clinical documentation for medical device technical files. You will identify, accumulate, review, and appraise clinical data from published literature and databases. You will manage the planning and execution of clinical studies for products from conception through testing and final reporting. Additionally, you will drive collaboration between cross-functional teams, including R&D, marketing, and global product management, to ensure that clinical research and documentation support product development goals.

Requirements

Bachelor's degree in engineering, life sciences, or a related field; or a qualified healthcare professional (e.g., Certified Orthotist, Physical Therapist, Occupational Therapist, Athletic Trainer, Nurse, Medical Doctor).
At least 3-5 years of experience in clinical research or regulatory documentation management for medical devices, with a proven track record of managing projects.
Strong experience in leading clinical studies, regulatory documentation, and cross-functional collaboration.
Previous experience with medical writing, clinical evaluation reports, and preparing documentation for regulatory filings (e.g., FDA, CE Mark).
Excellent communication and presentation skills, with the ability to communicate complex concepts clearly to both technical and non-technical stakeholders.
Strong organizational and project management skills, with the ability to prioritize and manage multiple projects simultaneously.
Expertise in MS Office applications (Word, PowerPoint, Excel), and familiarity with clinical research databases or regulatory submission platforms.
Strong attention to detail and a commitment to high-quality work.
Ability to collaborate effectively with diverse teams, both within the organization and externally.
Exceptional problem-solving skills and a proactive approach to overcoming challenges in clinical research and documentation.

Nice To Haves

A Master's degree or relevant certifications (e.g., Certified Medical Writer, Certified Research Associate) is a preferred.
Experience with DistillerSR a plus.

Responsibilities

Creation and review of critical clinical documents, including literature reviews, clinical evaluation reports, research protocols, trial outcome reports, and Institutional Review Board (IRB) submissions.
Ensure accurate and high-quality medical writing for product information, including clinical content for regulatory filings.
Provide strategic direction for drafting and reviewing clinical documentation in collaboration with internal and external stakeholders.
Design, implementation, and manage internal clinical research studies, ensuring alignment with organizational goals and regulatory requirements.
Supervise both qualitative and quantitative research processes, ensuring that studies are conducted efficiently and produce high-quality data.
Coordinate with cross-functional teams, including R&D, marketing, and global product management, to ensure alignment with clinical research goals and product timelines.
Drive accountability and ensure that all teams meet project deadlines, while maintaining high standards of clinical integrity and compliance.
Ensure that all clinical research activities comply with regulatory requirements, quality standards, and company policies.
All employees must be aware, have knowledge and shall have received general training in Quality requirements of Össur.
Exercises good use of company funds and property within the set guidelines.
Maintains an honest and professional attitude as the company’s representative at all times.
Contributes to a safe working environment by maintaining own workspace and reporting any potential hazards.