Director, Regulatory Affairs Americas

Main Purpose of Job

The Director Regulatory Affairs Americas supports the continued business expansion through new product registrations as well as renewal of existing registrations throughout the region, and ensures that adverse event reporting and change notifications are executed in a compliant manner for the Americas region, while demonstrating business acumen.

Role and Responsibilities

• Manage direct reports, including objective setting, performance review, coaching and development, and accurate budgeting
• Participate in local, regional and global level projects where regulatory input is required
• Develop Americas regulatory strategies in alignment with global strategy for new products
• Ensure close collaboration with the Global Regulatory Product Owners and other stakeholders in Americas so that the regulatory aspects of the assigned product family are managed efficiently and effectively during their lifecycle
• Provide regulatory inputs to the Americas Submission Plan to ensure that the plan is up to date, compliant with regulations, and at the same time meets the needs of the business
• Ensure that impact assessments for product and process changes will be conducted by the Global Regulatory Product Owner and required submissions and review times are incorporated in the overall Americas Submission Plan
• Direct the Global Regulatory Product Owner to ensure that all regulatory activities are aligned and executed per plan
• Accountable for timely approval for new product submissions, change notifications, license renewal to Americas regulatory authorities, and address questions and observations during the process
• Manage adequate and effective relationships with Third Party License Holders, Legal Agents, Regulatory Agencies, Consultants, and internal HOYA stakeholders to meet the regulatory goals and timelines
• Ensure that promotional and marketing materials used are compliant with internal and external requirements
• Maintain oversight of the changing regulatory environment across Americas, identify the risks and execute the plan to overcome the risks
• Responsible for adequate and effective relationship management with US FDA, Health Canada, Anvisa, other regional regulatory agencies, as well as with HOYA regional teams, including operations, R&D, GHQ, suppliers, and distributors
• Responsible for adequate and effective support of FDA audits in the HSO office globally

Education

• University Degree in Science (Pharmacy, Pharmaceutical Science) or related degree/diploma in Science, Engineering, and/or Biotechnology, or degree in Engineering or equivalent technical experience
• Master’s or Doctorate degree in above disciplines preferred

Experience

• Minimum 7 years of working registration experience in Regulatory Affairs in the Medical Device/Pharmaceutical industry, preferably in a multi-cultural environment in the US
• Managed submissions in a multi-product, multi-country environment through third parties
• Experience with the management of class IIb (preferably class III) medical devices in the Americas, Canada and LATAM
• Led a regulatory team at country or regional level and working at managerial level in-country

Skills

• Excellent project management skills
• Ability to translate complex technical matter into understandable submission documentation
• Excellent interpersonal and communication skills
• Able to work independently with minimal supervision
• Meticulous and attention to details.
• Strong technical writing skills
• Good communication skills across different departments and organizations

Travel Requirement

• Occasional travel to HOYA offices and regulators in the region. Ad hoc participation in cross functional project work as well as customers meetings.