Senior Manager, Regulatory Affairs

This is a fully remote position, open to applicants in Spain, +4 more countries.

📋 Description

• Oversee the planning and execution of client projects in accordance with established KPIs, timelines, budgets, and quality standards.

• Coordinate project teams, comprising both internal staff and qualified external partners, to ensure effective project delivery.

• Offer expert consultancy and practical guidance to clients and colleagues regarding Medical Device Services matters.

• Engage in regulatory, technical, and quality management activities for clients in the medical device and diagnostics sectors.

• Prepare, review, and compile documentation related to MDS assignments.

• Maintain communication with clients and Health Authorities.

• Assist in scientific advice procedures and represent clients during interactions with Health Authorities.

• Foster and sustain client relationships while identifying opportunities for enhanced service support.

• Contribute knowledge and insights to project staffing proposals and delivery planning.

• Stay informed about Medical Device Services intelligence and share relevant insights with colleagues.

• Deliver seminars, presentations, and lectures for colleagues, clients, and professional audiences.

• Contribute to the department’s expertise and best practices.

• Support the implementation of VDC strategy and its continuous optimization.

• Adhere to internal processes and contribute to their enhancement.

• Provide daily operational support to colleagues.

• Assist in commercial, marketing, and business development activities, including input for proposals.

• Supervise project delivery in line with budget and assist in resolving invoicing queries.

• Provide on-site regulatory support to GCS clients as agreed with the Head of VDC REG.

• Undertake other reasonable duties in accordance with the role and expertise.

⛳️ Requirements

• Demonstrated, extensive professional experience in regulatory affairs, medical device services, or a related specialized field.

• Strong expertise in medical technology and veterinary products.

• Proven experience in supporting medical advice activities; skills in medical advice are essential.

• Comprehensive knowledge of the discipline along with a strong understanding of business and client needs.

• Established ability to resolve complex problems and lead delivery within a specialized environment.

• Bachelor’s degree in Science or Engineering.

• Capability to translate strategic customer, partnership, or internal project goals into tactical plans with concrete milestones.

• Strong ability to define and manage escalation processes appropriately.

• Structured, analytical, systematic, and independent approach to work.

• Ability to prioritize tasks effectively and take action in accordance with operational policies and project requirements.

• Experience in leading complex project activities and providing guidance on change management.

• Ability to proactively identify opportunities for up-selling and cross-selling.

• Strong capability to identify, document, and help resolve project and program issues.

• Ability to lead project teams, coordinate work effectively, and align responsibilities with team strengths.

• Excellent relationship management skills with both internal stakeholders and external clients, including interaction with client department heads.

• Ability to align on mid-term goals and support the development of long-term client partnerships.

• Outstanding written and verbal communication skills.

• Proven ability to clearly communicate critical issues and recommend appropriate cross-functional solutions to decision-makers.

• Strong presentation skills and a confident, professional demeanor.

• Business fluency in English and the relevant local language.

🏝️ Benefits

• Benefit offerings outside the US may vary by country and will be aligned with local market practices.

• Commitment to equal employment opportunities and non-discriminatory practices in recruiting, training, compensation, benefits, promotions, and transfers.

• Provision of reasonable accommodations during the employment process for individuals with disabilities.