
Posted 21 days ago
Director, Regulatory Affairs Strategy
AlconDirector, Regulatory Affairs Strategy
Perks & benefits
Family Medical InsuranceHealth InsuranceMedical Insurance
Requirements
Bachelor's Degree or equivalent experience, 10 years relevant experience, 6 years leadership experience, English fluency
Skills
ComplianceMedical DevicesGxP
About the role
Responsibilities
- Lead the Regulatory Affairs Strategy department to develop and implement strategies aligned with company goals
- Direct the development and submission of product registrations, supplements, and periodic experience reports
- Provide strategic regulatory guidance to marketing and research teams regarding product development, safety, and efficacy
- Negotiate evidence requirements and regulatory strategies directly with health authorities
- Oversee the approval of promotional materials to ensure ethical conduct and regulatory compliance
- Manage post-approval commitments and product lifecycle management for the medical device family
- Supervise regulatory liaisons and focus on talent development to enhance team capabilities
Requirements
- Bachelor's Degree or equivalent years of directly related experience
- 10 years of relevant professional experience
- 6 years of demonstrated leadership experience
- Fluency in English (reading, writing, and communication)
- Experience working within GxP regulations and maintaining rigorous quality control
Benefits
- Robust benefits package including health and life insurance
- Retirement savings plans
- Flexible time off
- Opportunities for career growth in a highly collaborative environment
About the Company
Alcon is a global leader in eye care, dedicated to enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly to impact global eye health through advanced surgical equipment and consumer products. We foster an inclusive culture where every contribution helps make a difference in the lives of patients and customers worldwide.
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Alcon · Lake Forest
