What are the responsibilities and job description for the Regulatory Principal Specialist position at Alcon?
Job Title: Regulatory Principal Specialist
Location: Fort Worth, TX
Summary of Position:
The Principal Regulatory Specialist is responsible for the development and implementation of the regulatory strategy (as applied to project, process, and/or product), under limited supervision.
Key Responsibilities:
- Works in close collaboration with internal stakeholders and supports multiple projects.
- Provides support as needed for non-project related "regulatory excellence" activities.
- Ensures awareness of and compliance with global regulatory requirements and adherence to internal policies and processes.
- In a timely manner, provides solutions to a range of regulatory issues and has the freedom to act independently to execute.
- Provides high quality regulatory support for assigned products/projects.
- Partners with internal and external stakeholders (e.g., regions, Health authorities) to align on an optimized regulatory strategy in order to achieve business objectives.
- Drives superior results by taking initiative, planning and implementing projects, setting priorities and holding self and others accountable to meet commitments.
- Develops documents that are clear, concise, and complete to facilitate reviews/approvals.
- Develop and manage global regulatory strategies to maximize the value of the products/projects.
Preferred Knowledge and Skills:
- PMA, class 3 experience in the US, some European classification, strategic abilities for change management.
- Formulary experience, someone who has been in a aseptic facility, medical device experience, pharma experience.
Education and Work Experience:
- Minimum: 3-5 years’ experience in a Medical Device or related field having comparable technology and regulatory requirements.
- Preferred: Over 5 years’ experience in a similar role in a highly regulated environment.
Language:
- Exceptional written and verbal English communication skills are required.
Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.
