Regional Regulatory Affairs Associate Director
2 days ago
The Associate Director, Regulatory Affairs APAC Vision Care is responsible for all aspects of regulatory responsibilities in APAC VC. Critical to this role is to combine knowledge of scientific, regulatory, and business issues to enable all products that are developed, manufactured, or distributed to meet all the required legislations in all applicable markets. Additionally, this role is responsible for directing post-marketing Lifecycle Management (LCM) Regulatory activities (e.g., claims, change management, regional re-registrations, copy clearance, global LCM labeling support, and external environment surveillance). The Associate Director will be a member of AP RA VLT Team. The Associate Director will develop, actively mentor and supervise a team of regulatory professionals in APAC. This role has market & business level influence and responsibility and is considered a key opinion leader and an expert resource within JJ VC and externally on all regulatory matters across the region. This Associate Director will be actively called upon to influence changing regulations and guidance, interface with external regulatory agencies and trade associations and to provide executive management with regulatory metrics/information.
- Identifies and manages risks and business needs. Ensures the development and implementation of leading-edge systems and practices internally/across sites/companies. Identify and implement new regulatory policies, processes and SOPs, as appropriate.
- Sponsors departmental and cross-functional team development. Removes barriers. Provides project leadership or participates as a team member on major initiatives that have high impact to the business. Key member of leadership team. Applies influence across departments and the business.
- Anticipate emerging issues and develop solutions.
- Prepare and manage the budget (OOS/FTE) for department.
- Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions
- Develop corporate positions on regulatory risk-benefit
- Integrate regulatory considerations into the corporation’s global product entry and exit strategy
- Recruit, develop, and mentor regulatory professionals
- Provide guidance for resource and development planning
- Provide regulatory input for follow-up to inspections and audits to minimize potential for findings of noncompliance
- Represent regulatory affairs in product recall and recall communication process
- Manage processes involved with maintaining annual licenses, registrations, listings, and patent information
- Review and approve publicly disseminated information to minimize regulatory exposure; review product claims, and preserve confidentiality of applicable product information
**Qualifications**:
- A Bachelor’s degree / Master Degree is preferred
- At least 10 to 15 years of relevant experience from medical device or medical technology field
- Sound knowledge of regulatory and business strategies to gain and maintain the legal marketing status of the product portfolio.
- Excellent organizational, communication, negotiation, and interpersonal skills.
- Ability to effectively negotiate and influence upper management, affiliates, regulatory agencies, and industry to ensure that regulatory and business needs are met.
- Flexible to accommodate to business travel 10% to 20%
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