Director Regulatory, APAC - Singapore

Role Purpose

The Regulatory Director will be anticipating and shaping the environment across APAC & ANZ, enabling Cynosure to lead through innovation.

Role is responsible to lead and/or participate in cross functional and cross company interdisciplinary teams responsible for defining and implementing regulatory strategy in APAC and ANZ. Manage regulatory interactions with distributors, consultants or partners to achieve regulatory objectives in line with individual development and corporate goals. Primary contact with regulatory authorities in Asia & ANZ.

Role Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

Leadership:

• Lead/participate in cross functional and cross company interdisciplinary teams establishing international regulatory strategy for commercial products.
• Play a thought and people leadership role within the Global RA community
• Build strong teams with peers and local market experts based on functional expertise and mature leadership personality
• Represent RA in the Leadership Team, creating transparency through proactive collaboration within the matrix

Strategy:

• Establish Cynosure as a shaping influence in the regulatory environment across key markets
• Create APC/ANZ RA strategy and ensure it dove-tails and complements the Global Strategy
• Shorten lag times between innovation and ability to implement in global key markets
  • Deep dive into key Asian markets and establish root cause issues for lag times
  • White paper of fast changing regulatory environment
• Scan changing ongoing regulatory environment and proactively incorporate changes into strategy as well ensure business readiness
• Within the approved strategy set clear priorities and achieve alignment with key stakeholders

Operations:

• Manage and resolve the tension between global excellence and new innovation with local execution challenges
• Drive Efficiency
  • Drive regulatory approvals by providing clear project priorities.
  • Improve internal systems/processes to ensure ability to be proactive in approach (eg planning)

• Drive Effectiveness
  • Support post-market surveillance efforts monitoring the performance of Cynosure devices.
  • Ensure competent execution of agreed priorities through working with all relevant stakeholders and guard against distraction/ competing enterprise asks
  • Ensure all APAC/ANZ marketing material is in line with local regulatory requirements.

• Leverage regular Influencing Conversations to build Cynosure’s shaping influence
  • Maintain communication with Regulatory Bodies as necessary.
  • Manage regulatory interactions with distributors, consultants or partners.

• Monitor and ensure both compliance with and documentation of compliance with Cynosure’s policies and procedures as outlined in various Company policies, including the Global Approval Authority Matrix and other mandatory policies pursuant to one’s job description.

Education & Experience

• BA/BS required. Master’s degree preferred
• 15+ years’ experience in a medically regulated and technical environment with at least 5+ years in a medical device company.
• Knowledgeable of medical device regulation in Asia, Europe and Latin America.
• Min 5 years of people leadership in a matrixed and geographically environment
• Technical/Functional Experience:
  • Experience with successful preparation and submission of applications in APAC & ANZ regions, including (but not limited to) countries such as China, Japan, Taiwan, Korea, and Australia.
  • Experience with aesthetic medical devices. Experience with aesthetic lasers is a plus.
  • Experience in supporting international registrations
  • Excellent knowledge of ISO13485.
  • Strong understanding of marketing and promotional requirements in Europe and Asia.
  • Strong working knowledge of FDA regulations, including knowledge of medical device development process and related FDA regulations across full product life cycle
  • Experience with ISO 14155 and other clinical regulatory requirements is a plus

Competencies

• Strong attention to detail and well-developed analytical thinking skills
• Strong project organization and time management skills, including the ability to prioritize multiple challenging project timelines while ensuring all deadlines are met
• Ability to take initiative and work autonomously without significant direction, implementing judgment to resolve objective
• High level of spoken and written English
• Strong influencing and negotiating skills with very senior internal and external stakeholders
• Excellent communication skills; written and verbal

• Learning Agility, with emphasis on Mental agility and Change agility
• Strong conceptual thinking
• Strong problem-solving skills

• Passion for results
• Strong matrix influencing skills
• Building organizational talent
• Proven ability to balance autonomy and collaboration

Personal Attributes

• Is resilient
• High level of integrity
• Accurate self-insight
• High learning orientation
• Calm under pressure