ASPAC Regulatory Policy Director,leading medical device company

Our client, one leading medical device company is seeking a ASPAC Regulatory Policy Head role, Profile Search & Selection is acting as the Employment agency in relation to this vacancy.

Job Title: MD ASPAC Regulatory Policy Head (Director level)

Department: MD, RA, Regulatory Policy

Reports To: Sr Director, Global Regulatory Intelligence

OVERALL RESPONSIBILITIES:

Serves as the MD RA leader monitoring the Asia-Pacific regulatory landscape for changing regulatory requirements and opportunities. Communicates dynamic regulatory information into Sr. Director, MD Global Regulatory Intelligence.

POSITION DUTIES & RESPONSIBILITIES:

Key responsibilities include:

• Serves as primary ASPAC legislative and regulatory expert
• Serves as the principal MD RA leader shaping and implementing the extremely fast pace and changing regulatory platform in key region.
• Proactively monitors ASPAC HA activity through systematic review of regulatory requirements.
• Identifies, cultivates, and nurtures relationships with ASPAC HAs necessary to proactively monitor regulatory changes and trends.
• Assesses changes in ASPAC regulatory policy and analyzes impact on MD RA and individual Business Units.
• Provides consistent and timely information to Sr. Director, MD Global Regulatory Intelligence on the dynamic global regulatory landscape.
• Manage J&J and Trade Assn. responses to proposed ASPAC regulatory changes.

Functional and Technical Competencies:

• Knowledge of China, Japan, India and other ASPAC regulatory requirements, processes, and organizations across the medical device field.
• Ability to articulate regulatory policies and their implications to multiple audiences (internal and external).
• Work effectively with internal/external corporate regulatory groups, HAs, and trade associations to efficiently monitor regional regulatory policy.
• Strategic thinking and ability to partner with key external HA stakeholders at senior levels.

Leadership Competencies:

• Connect - Must develop and maintain regional relationships with key stakeholders (HAs, trade associations) and internal partners (Regions and BUs).
• Shape - Must manage and shape internal responses to proposed Tier 2 policy changes.
• Lead - Effectively drives regional regulatory intelligence across MD.
• Deliver - Ability to achieve results under demanding time constraints with expansive and changing priorities.

EDUCATION & EXPERIENCE REQUIREMENTS:

• Master's degree or equivalent required.
• Minimum 10 years of progressive experience in regulatory policy, public policy, government relations, or regulatory affairs leadership within the medical devices or related (healthcare, pharmaceutical) industry.
• Strong political acumen.

Demonstrated leadership skills; responsibility for influencing external industry peers in building consensus for regulatory policy.