Regulatory Affairs Manager – Clinical Evaluations
Our client is a medical technology company dedicated to advancing the treatment of ear, nose, and throat (ENT) conditions through evidence-based innovation. We provide treatments for people with chronic sinusitis, an inflammatory sinus condition that has been shown to substantially reduce quality of life. Our clients core technology is an absorbable, steroid eluting implant which is a fascinating Class lll medical device which drastically improves patients’ quality of life.
PURPOSE OF JOB:
The primary function of a Regulatory Affairs Project Manager, Clinical Evaluations is to execute global regulatory strategies and policies from clinical evaluation and post market surveillance (PMS) perspective for specific new products and solutions, include Electromagnetic Navigation System for ENT and Spine, medical device software and other reusable/sterile surgical instruments in order to meet global regulatory requirements. Support Regulatory Affairs medical device submissions worldwide.
Responsible for implementing regulatory requirements for clinical and post market surveillance in accordance with EU MDR 2017/745, MDD 93/42/EEC, ISO13485: 2016 and other jurisdictions as required.
Participate in the strategy of product global registration from clinical perspective, proactively address potential risks for clinical evidence for regulatory submission and ensure the implementation & updating of clinical strategy throughout the global approval cycle.
Ensure the compliance of global regulatory affairs activities with applicable company policies and procedures.
Develop and update new policies, as appropriate, for processes and procedures relating to the clinical evaluation process, and train key personnel on them.
CER project management, including project plan, change management, status tracking and control, review and risk assessment.
Lead projects and oversight to external CRO consulting firms including:
Clinical evaluation plans (CEPs) and Clinical Evaluation Reports (CERs)
Clinical literature search protocols
Clinical literature search reports
Participate in and/or lead the development of regulatory responses for questions from Notified Body, global regulators, and regulatory representatives upon review of submissions in relation to Clinical Evaluation, Post Market Surveillance and Post-Market Clinical Follow-Up.
Participate in and support audits and responses to audit findings as appropriate, in root cause analysis, preventive or corrective actions, effectiveness monitoring, and other quality metrics.
Facilitate communication and exchange of documents between stakeholders (e.g., cross-functional teams as well as external vendors such as CROs, Medical Writers and Physician Reviewers.
Evaluate the safety and performance and benefit/risk profile of a device over its lifecycle to provide strategic guidance on regulatory requirements and ensure clinical data and clinical evaluations activities & documentation for pre-market products are completed as per the design control process and procedures.
Contribute to other activities such as process improvement, risk assessment and management, review of regulatory and informational documents such as the Instructions for Use (IFU).
What you bring:
Bachelor’s degree in the sciences or medicine
Minimum 8 years of experience in regulatory affairs, clinical research, clinical affairs, medical affairs, study manager and medical writer in the medical device industry
Experience in writing, reviewing or leading clinical and post market study development of clinical protocol and related documents in accordance with EU MDR 2017/745, MDD 93/42/EEC; MEDDEV 2.7/1 Rev 4, MDCG Guidance on clinical evaluations, PMCF plans and reports, and other guidance, regulation, standards and guidelines of medical devices, clinical studies, and quality systems outside the European Union.
Strong command of medical terminology.
Scientific/research background; Knowledge of applied research design, methodology, and statistics for the purposes of regulatory submission and peer-reviewed publications.
Ability to read, analyze, and interpret professional journals, technical procedures, or governmental regulations. Ability to write reports and business correspondence. Ability to effectively present information and respond to questions from groups of managers, global distributors, and authorities.
Project management experience.
Experience with Good Laboratory Practice (GLP) and/or Good Clinical Practice (GCP) preferred.
Experience with medical devices in Electromagnetic Navigation System for ENT and Spine, medical device software or other reusable/sterile surgical instruments preferred.
Certification is a plus (e.g., RAC device and/or PMP) preferred.
Skills and Competencies:
Fluent in English is a must.
Excellent written and verbal communication skills, presentation skills, strong documentation skills, strong attention to details and medical writing including authoring regulatory and clinical documentation, SOPs, product manuals, Instructions for Use (IFUs), process flows and work instructions.
Systems Knowledge such as RA systems, QMS system, Agile, ComplianceWire, Wrike, Retina or CAQ Quality Management Systems.
Excellent organizational skills.
Must be able to handle multiple projects and effectively manage priorities with stakeholders in a fast-paced environment.
Demonstrated creative solution design for complex problems.
Results oriented and successful in driving accountability through influence of cross functional team members without direct authority.
Demonstrated ability to succinctly and accurately communicate to various levels of management and across the organization.
Experience working with medium size and start-up companies.
28 days holiday
Friendly and Supportive culture (A good culture is a core focus for our client)
Full-time Permanent Position
Great Location just outside of Berlin
Flexible Working Hours
To apply or show an interest please email Luke at email@example.com