Regulatory Compliance Specialist

COMPANY DESCRIPTION:

Santen is a specialized pharmaceutical company with a 130-year heritage focused exclusively on ophthalmology. With sales in over 60 countries, Santen’s 4,000 global employees work to deliver life-changing therapies that make hope a reality for people facing vision impairment and loss. Santen Inc., located in Emeryville, CA (North America HQ), contributes important research & development and commercialization efforts. This office is home to about half of our 350-total staff in North America, including our Toronto, Canada site and our recent acquisitions of Eyevance Pharmaceuticals (Fort Worth, TX) and InnFocus (Miami, FL). 

We are in search of top talent to help us meet our important goals and large growth plans.

ABOUT THE POSITION:

We are seeking a results-driven regulatory compliance specialist to implement and develop regulatory compliance strategies. You will be reviewing documentation and procedures, collaborating with internal and external stakeholders on compliance-related issues, and performing compliance audits.

To ensure success as a regulatory compliance specialist, you should exhibit extensive experience in regulatory compliance coordination and in-depth industry knowledge. An accomplished regulatory compliance specialist will be someone who can facilitate regulatory compliance to help our organization maintain an excellent reputation.

ESSENTIAL DUTIES AND KEY DELIVERABLES:

• Reviewing documentation, processes, and practices
• Developing and enacting regulatory compliance strategies
• Coordinating regulatory compliance procedures across organizational structures
• Providing training in compliance practices and procedures
• Monitoring compliance and facilitating interventions to manage risks
• Performing compliance audits and compiling reports
• Documenting compliance-related processes and maintaining records
• Keeping abreast of regulatory changes and developments in the regulatory environment
• Perform complaint investigations to ensure compliance with all FDA regulations and standards related to the review of events/complaints for products
• Collaborate with appropriate clinical, technical, and/or regulatory employees to determine product event status and MDR reportability
• Assures timeliness and compliance with all FDA regulations and standards related to the review of events/complaints for products
• Coordinate, research, and prepare correspondence in response to FDA and global regulatory agencies requests for additional information
• Collaborate with global complaint handling and adverse event reporting activities related to products
• Provide support for internal quality audits of complaint files / MDR documentation, as well as external audits/inspections from Regulatory Bodies
• Comply with the site Quality System
• Performs other duties as assigned

QUALIFICATIONS:

• Bachelor's degree in Sciences
• More than five years' work experience in the relevant industry
• At least three years’ experience as a regulatory compliance specialist, or similar
• Knowledge of industry regulations and governing laws
• Proficiency in office and compliance management software
• Exceptional analytical, investigative, and organizational skills
• Excellent interpersonal and communication skills

Location:

• Miami, FL

COVID-19 Vaccination Requirement: Santen requires anyone working on-site or visiting company offices to confirm they are fully vaccinated against COVID-19 unless a medical or religious accommodation is timely requested and approved. Please reach out if you have questions or concerns about this policy and how it may apply to your candidacy for a role with Santen.

For more information about our company and the work experience, please visit www.santenusa.com and https://www.innfocusinc.com/