Senior Manager, Regulatory Affairs

Job not on LinkedIn

đŸ”„ 6 minutes ago

🌐 Spain, Germany, +3 more countries – Remote

infoinfo

⏰ Full Time

🟠 Senior

🚔 Compliance

Apply Now
Find Similar Remote Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Logo of Cencora

Cencora

10,000+ employees

đŸ’Œ Consulting

📩 Logistics

đŸ„ Healthcare

Consulting ‱ Logistics ‱ Healthcare

Cencora is a company dedicated to improving the health and well-being of both people and animals globally. Built on the legacy of AmerisourceBergen, Cencora offers a wide range of industry-leading solutions that encompass specialty logistics, warehousing, drug research, clinical development support, and more. They provide commercialization and patient access support and offer wholesale and specialty distribution services. Cencora serves a diverse clientele, including pharmaceutical companies, physician practices, pharmacies, and health systems. The company also extends its services to animal health, managing operations and delivering products for animal pharmaceutical care. With a strong global footprint, Cencora aims to reshape healthcare delivery through innovative products and solutions, striving to create healthier futures for all.

📋 Description

‱ Lead the planning and execution of client projects in line with agreed KPIs, timelines, budgets, and quality standards ‱ Coordinate project teams, including internal colleagues and qualified external partners, to ensure effective delivery ‱ Provide expert consultancy and practical guidance to clients and colleagues on Medical Device Services matters ‱ Participate in regulatory, technical, and quality management activities for medical device and diagnostics clients ‱ Prepare, review, and compile project documentation within MDS assignments ‱ Communicate with clients and Health Authorities ‱ Support scientific advice procedures and represent clients in interactions with Health Authorities ‱ Build and maintain client relationships and identify opportunities for increased service support ‱ Contribute knowledge and insight to project staffing proposals and delivery planning ‱ Maintain awareness of Medical Device Services intelligence and share insights with colleagues ‱ Deliver seminars, presentations, and lectures for colleagues, clients, and professional audiences ‱ Contribute to department expertise and best practices ‱ Support VDC strategy implementation and continuous optimization ‱ Comply with internal processes and contribute to their improvement ‱ Provide day-to-day operational support to colleagues ‱ Support commercial, marketing, and business development activities, including proposal input ‱ Oversee project delivery against budget and support resolution of invoicing queries ‱ Provide on-site regulatory support to GCS clients where agreed with the Head of VDC REG ‱ Undertake other reasonable duties aligned to the role and expertise

🎯 Requirements

‱ Proven, in-depth professional experience in regulatory affairs, medical device services, or a related specialist field ‱ Strong expertise in medical technology and veterinary products ‱ Demonstrated experience supporting medical advice activities; medical advice experience and skills are essential ‱ Extensive knowledge of the discipline and strong understanding of business and client needs ‱ Proven ability to solve complex problems and lead delivery within a specialist environment ‱ University degree in Science or Engineering ‱ Ability to translate strategic customer, partnership, or internal project goals into tactical plans and concrete milestones ‱ Strong ability to define and manage escalation processes appropriately ‱ Structured, analytical, systematic, and independent approach to work ‱ Ability to prioritize effectively and take action in line with operational policies and project requirements ‱ Experience leading complex project activities and providing guidance related to change management ‱ Ability to proactively identify up-selling and cross-selling opportunities ‱ Strong capability to identify, document, and help drive resolution of project and program issues ‱ Ability to lead project teams, coordinate work effectively, and align responsibilities to team strengths ‱ Strong relationship management skills with internal stakeholders and external clients, including engagement with client department heads ‱ Ability to align on mid-term goals and support the development of long-term client partnerships ‱ Excellent written and verbal communication skills ‱ Proven ability to communicate critical issues clearly and recommend appropriate cross-functional solutions to decision-makers ‱ Strong presentation skills and a confident, professional presence ‱ Business fluency in English and the relevant local language

đŸ–ïž Benefits

‱ Benefit offerings outside the US may vary by country and will be aligned to local market practice ‱ Equal employment opportunity and non-discriminatory recruiting, training, compensation, benefits, promotions, and transfers ‱ Reasonable accommodations during the employment process for individuals with disabilities

Apply Now

Similar Jobs

🕒 Yesterday

ERGOMED

1001 - 5000

đŸ’Œ Consulting

đŸ„ Healthcare

📩 Logistics

Study Start-Up and Regulatory Affairs Specialist leading regulatory submissions and site readiness for Ergomed’s rare disease and oncology clinical trials. Coordinating multi-country compliance, agreements, and study documentation.

🕒 October 13

Ibertech IT Services

51 - 200

đŸ’Œ Consulting

📩 Logistics

📣 Marketing

Consultor SAP IAM & GRC para implementar y mantener soluciones de identidad y gobierno de accesos. Gestionando proyectos e integraciones SAP cloud y on-premise desde España.

đŸ—ŁïžđŸ‡Ș🇾 Spanish Required

🕒 October 9

Yuno

11 - 50

💳 Fintech

🏱 Enterprise

☁ SaaS

Security Compliance Engineer supporting Yuno’s global payments infrastructure through ISO, SOC 2, and PCI DSS audits. Building Python tooling and implementing AWS/GCP security controls.

🕒 September 29

Plain Concepts

201 - 500

đŸ’Œ Consulting

📣 Marketing

📩 Logistics

AI Security Governance Consultant helping Plain Concepts clients establish scalable AI security governance. Translating technical risks into business strategies, controls, and adoption frameworks.

đŸ—ŁïžđŸ‡Ș🇾 Spanish Required

🕒 September 25

Thermo Fisher Scientific

10,000+ employees

đŸ„ Healthcare

📩 Logistics

🏭 Manufacturing

Clinical Compliance Manager overseeing GxP audits, CAPA, and quality assurance for Thermo Fisher Scientific’s clinical development programs. Fully remote in Spain.