Senior Clinical Affairs Specialist

Integer

Remote, Ireland

What you’ll do in this role:

The primary purpose of this role is to ensure successful conduct and delivery of all clinical programs for Integer technologies consistent with research and development, marketing and regulatory plans across the organization. This position will also support compliance with all relevant regulatory, clinical, and standard requirements that apply

You will adhere to Integer Core Beliefs and Values, all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
You will develop global clinical strategies to support clinical evidence requirements for product submissions.
You will develop and work within specific processes to support any required post submission activities (e.g., Post Market Clinical Follow Up data generation and evaluation).
You will represent the Clinical Affairs function on product development teams.
This position will also support compliance with all relevant regulatory, clinical, and standard requirements that apply
You will advance clinical data integrity in support of the quality and regulatory functional group needs. This will include the use of software to appraise, analyse and evaluate clinical and state of the art data to generate appropriate clinical evidence to support Integer Technologies and Projects, and management of any updates to appraisal forms, workflows, reporting outputs.
You will be first author and responsible for the generation of interim and final reports.
You will support Integer initiatives with market specific clinical training.
You will convene and direct investigator conferences to review findings and advise on direction.
You will select, interface with, and assure training of investigators/physicians, centre staff and Integer Clinical Affairs staff.
You will provide a clinical perspective and approval on field complaint investigations, recall decisions or other instances where a clinical opinion is needed
You will ensure adequate monitoring is conducted on all clinical trials.
You will work directly with regulatory bodies for the purpose of facilitating regulatory approvals and queries.
You will support the development of Integer technology including objectives, strategy, scope, budget, and schedule from proof of concept through post-commercial regulatory.

How you will be measured:

The specific measures listed below may be subject to change and are not intended to be an all-inclusive list.

Safety is our highest priority; you will be an active supporter of the Integer Environmental, Health & Safety programs and the specific behavior-based safety programs
You will have defined Goals and Objectives specifying key projects and expected milestones to achieve.
- Ensure clinical data arguments provided in clinical documentation (Clinical Evaluation, Post Market Clinical Follow up, etc.) are sufficient to support regulatory product approvals
- Support revenue growth by leveraging clinical knowledge to support the growth team initiatives
- The creation of market specific clinical training
- Ensure documentation and data are maintained to reflect State of the Art
- Ensure State of the Art clinical processes are maintained and continuously underpinned by current knowledge and insight gained
- Support the Development and maintenance of the physician advisory board to and its functions as directed
- Cost -You will be expected to complete clinical inputs for product approval and product renewal within budget
- On-Time Delivery - particularly those that are impacted by the results of projects that you are involved in, and delivered by specified milestones
- Your expertise coupled with your accomplishments and collaboration with others to deliver results will also be considered.

What sets you apart:

You have a degree from higher education (Science, Engineering, Health Science, Nursing or related field)
You are regarded as a subject matter expert with 5 years of documented professional experience; or 10 years of documented professional experience if a degree is not a prerequisite for a given task.
You have experience in medical device industry or pharmaceutical industry including US and international medical device regulatory submissions/approvals.
You have experience with implantable devices and/or other high-risk device types.
You are suitably qualified as per MEDDEV 2.7.1 (rev 4), section 6.4 with experience of research methods, information management, systematic literature reviews and medical writing.
You have shown the ability to plan, manage and execute clinical evaluations autonomously
You have in-depth knowledge with various medical device regulations such as the Medical Device Regulation (2017/745), 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
You have knowledge and experience with current US-FDA, ISO and other related quality and regulatory system requirements and how they interact with the business
You have experience working with the medical community including physicians.
You have clinical experience with feasibility, pivotal and post-market clinical trials.
You have shown the ability to work independently to achieve goals without direction
You have also shown the ability to work collaboratively as well as both vertically and horizontally across the organization.
You have well-developed written and oral communication skills. This includes the ability to act as a coach to teach and train less experienced or knowledgeable associates. Clear and professional communications to all levels of the organization are important in this role
You have experience working in ERP systems, (such as Oracle, Reliance, etc.), Minitab, Excel, etc.
You have strong leadership skills with demonstrated ability to drive positive results and deliver projects and their deliverables on time and within budget.