Clinical Affairs Specialist III

Integer Holdings Corporation

5d•$75,750 - $111,000•Remote

About The Position

This role contributes to global clinical strategies to support clinical evidence requirements for product submissions and post-submission activities. The specialist will represent the Clinical Affairs function on product development teams, working with cross-functional areas possibly in multiple geographical locations. Key responsibilities include ensuring clinical data integrity for quality and regulatory needs, using software to analyze data for clinical evidence, generating reports, supporting market-specific clinical training, and assisting with investigator conferences. The role also involves training investigators, center staff, and internal teams, ensuring adequate monitoring of clinical trials, providing clinical perspective on field complaint investigations, and working with regulatory bodies for approvals and queries. Additionally, the specialist will support the development of Integer technology from concept through post-market phases and perform other required functions.

Requirements

Degree from higher education (Science, Engineering, Health Science, Nursing or related field)
3 years of documented professional experience; or 5-7 years of documented professional experience if a degree is not a prerequisite for a given task.
Experience in medical device industry or pharmaceutical industry including US and international medical device regulatory submissions/approvals.
Experience with implantable devices and/or other high risk device types.
Suitably qualified as per MEDDEV 2.7.1 (rev 4), section 6.4 with experience of research methods, information management, literature reviews and technical writing.
Knowledge and experience of clinical evaluations.
Knowledge and experience with various medical device regulations such as the Medical Device Regulation (2017/ 21 CFR Part 812, and standards guidance documents such as MEDDEV 2.7.1 (rev 4) MDCG 2020 5, MDCG 2020 6, ICH Guidelines and their application.
Experience working with the medical community including physicians.
Knowledge of feasibility, pivotal and post market clinical trials.
Ability to work independently as well as collaboratively within the organization.
Developed good written and oral communication skills.
Ability to assist in teaching and training less experienced or knowledgeable associates.
Clear and professional communications to all levels of the organization.
Experience working in ERP systems, (such as Oracle, Reliance, etc.), Minitab, Excel, etc.
Leadership skills with demonstrated ability to drive positive results and deliver projects on time for deliverables and within budget.

Responsibilities

Contribute to global clinical strategies to support clinical evidence requirements for product submissions and post submission activities.
Represent the Clinical Affairs function on product development teams.
Work directly with representatives from cross functional areas in possibly multiple geographical locations.
Ensure clinical data integrity in support of the quality and regulatory functional group needs.
Use software to appraise, analyse and evaluate clinical and state of the art data to generate appropriate clinical evidence to support Integer Technologies.
Generate interim and final reports.
Support Integer initiatives with the development and upkeep of market specific clinical training.
Support investigator conferences to review findings and advise on direction.
Interface with, and assure training of investigators/physicians, centre staff and Integer Clinical Affairs staff.
Support adequate monitoring is conducted on all clinical trials.
Provide a clinical perspective and approval on field complaint investigations.
Work with regulatory bodies for the purpose of facilitating regulatory approvals and queries.
Support the development of Integer technology including objectives, strategy, scope, budget, and schedule from proof of concept research, development through post market commercial phases.
Perform other functions as required.