Abbott Global Regulatory Operations Clinical Risk Management Scientist in Zaventem, Belgium
We are looking for a high caliber Global Regulatory Operations Clinical Risk Management Scientist to provide scientific expertise throughout product development related to management and alignment of risk information for Cardiac Rhythm Management (CRM) and/or Heart Failure (HF) management and/or Vascular products.
Core Job responsibilities
Independently creates and maintains RMLs and PSURs for Abbott products. Maintains thorough knowledge of assigned products. Identifies appropriate sources of relevant data, interprets, evaluates and incorporates information from various sources including literature, clinical data, and medical references. Oversees CROs, actively manages timelines and project delays/risks, develops scenario’s and recommendations for management.
Leads risk alignment committee meetings (departmental multidisciplinary team), facilitates therapeutic team participation as appropriate, facilitates informed decision-making and dissemination of scientifically balanced and quality risk information regarding products. Ensures effective communication to clinical safety, clinical science, clinical internal and external operations, post market surveillance, medical affairs, clinical R&D, quality engineering, regulatory affairs, product labelling, sr management, and external CROs or medical writers. Conducts team meetings, sends routing communications and/or presents regular updates to senior staff.
Reviews Risk Assessment Matrices (RAMs), Clinical Evaluation Plans and Reports (CEP/CER), Instructions For Use (IFU), patient guides, Investigator Brochures (IBs), Clinical Investigation Protocols (CIPs), and clinical investigation Informed Consent Forms (ICF), ensuring alignment of risk information. Involves in responses to complex costumer queries (e.g. regulatory authority, ethical committee, …) related to risk information. Reviews and gives input to Post-Marketing Surveillance Plans (PMS) and Post-Marketing Clinical Follow-up Plans (PMCF).
Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.
Responsible for compliance with applicable corporate and divisional policies and procedures. Ensures compliance to applicable regulations (ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1, EU and FDA guidance documents) and DOPs.
Develops and maintains RML DOP, PSUR DOP, and associated documentation, provides input to cross-departmental SOPs and DOPs describing risk information processes. Develop templates taking into account all applicable regulations.
Provide and implement innovative ideas and solutions to clinical risk management group (e.g. database, LEAN projects), develop and roll out functional trainings as required.
Participates in and supports audits. May actively participate in root cause analysis, preventive or corrective actions, and effectiveness monitoring, as requested by management
Acts as a mentor to less-experienced staff
Advanced biomedical degree, e.g. MD, PhD, Pharm D. Must be familiar with medical conditions. MD preferred.
Minimum experience/training required
Experience in clinical research and/or risk surveillance and management and/or clinical evaluation reports (medical devices or equivalent in pharmaceuticals) and/or regulatory affairs. The minimum number of combined years of experience must equal 5.
Experience in cardiac rhythm management, or heart failure, or vascular therapeutic areas is desired.
Experience in Medical Devices and/or Active Medical Devices (firmware, software) and/or Active Implantable Medical Devices is desired.
Knowledge of EU MDD/MDR, FDA medical device regulations, ISO13485, ISO14791, ISO14155, MEDDEV 2.7.1 Rev 4 (or equivalents in pharmaceuticals)
Needs to have worked in a quality environment before
Good analytical skills, literature evaluation skills, ability to critically evaluate medical data. Able to independently write routine technical documents, and perform independent analyses. Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Must have solid clinical understanding of disease state and the implications of treatment as it relates to the patient.
Proven written and verbal communication skills in a team setting and/or informal leadership role.
Uses in-depth knowledge of business unit functions and cross group dependencies/ relationships. Is recognized as an expert in work group and across functions. Knowledge of functional areas involved in RAMs, CEPs/CERs, IFUs, patient guides, IBs, CIPs, and study ICFs.
Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org