Job Summary:
Alvotech is actively seeking a Risk Lead for its innovative Combination Products and Devices team in Stockholm, Sweden. The successful candidate will be responsible for compiling and maintaining risk management files for Alvotech’s combination products, ensuring alignment with international medical device regulations. This role offers an excellent opportunity for experienced risk management professionals to contribute to cutting-edge pharmaceutical developments and make a meaningful impact on patient safety worldwide.
Key Responsibilities:
Compile and maintain risk management files for Alvotech’s combination products in compliance with international standards.
Collaborate with medical experts and external consultants to gather input on harm evaluation for risk assessments.
Develop and update company procedures governing medical device risk management.
Conduct periodic reviews and revisions of risk management documentation based on evaluations or product complaints.
Deliver risk management training and knowledge-sharing sessions to internal teams.
Lead internal and external stakeholder engagements to ensure risk-related process alignment.
Drive continuous improvement initiatives in risk documentation and management practices.
Required Skills & Qualifications:
Master’s Degree in a relevant scientific or engineering field.
Minimum of 5 years of professional experience in risk management or related roles within the pharmaceutical or medical device industry.
Strong leadership and strategic thinking capabilities.
Proven decision-making and problem-solving skills in complex environments.
Ability to work independently with a high level of accountability.
Broad understanding of the pharmaceutical product lifecycle and value chain.
Experience in cross-functional collaboration with internal and external stakeholders.
Excellent verbal and written communication skills in English.
Service-oriented with a proactive, hands-on attitude and teamwork mindset.
Perks & Benefits:
Opportunity to work on transformative healthcare projects impacting global health.
Part of a fast-growing, international biopharmaceutical company.
Collaborative and inclusive work culture fostering innovation.
Clear career progression pathways with personal growth support.
Company-sponsored social events and milestone celebrations.
Excellent in-house cafeteria and wellness programs.
Eco-friendly transportation support and on-site facilities.
Positive, flexible, and empowering work environment.
Company Description:
Alvotech is a global biopharmaceutical leader committed to improving patient access to affordable biologics. With a focus on biosimilars and combination products, Alvotech pioneers innovation in drug development while maintaining the highest regulatory and quality standards in the healthcare industry.
Work Mode:
On-site – Stockholm, Sweden
Call to Action:
If you’re a proactive risk management expert ready to drive safety and compliance for advanced pharmaceutical products, apply now to join Alvotech’s pioneering team in Stockholm.
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