You are responsible for
- Formulating and implementing the Businesses and APAC Zone long-range regulatory strategies and policies.
- Create regulatory awareness level as determined within the organization.
- Enforce simplified yet robust regulatory processes and harmonizes them across the Clusters and Businesses and Markets and Functions; establishing an effective Management Review process, including routine reporting.
- Introduce and implement the necessary regulatory processes and tools required to ensure first time right in submissions.
- Manage compliance to local regulatory requirements across APAC, in addition FDA, EU-MDR regulations and other Regulatory Requirements and as required, guidelines and policies to all products and operations are consistent with those regulations.
- Lead the Planning, generation, and coordination of regulatory submissions for product/solution licensing.
- Proactive stakeholder management in BU.
- Define and implement appropriate regulatory certifications for sites
- Ensures that all products to be released comply with all the relevant safety and environmental policies and regulations by implementing requirements, conditions and enablers in the Business and / or Region/ Zone.
- Establishes operational objectives and work plans, and delegates assignments to subordinates.
- Formulates and recommends (changes to) policies and establishes procedures that affect immediate organization(s)
- Facilitate the coordination of the activities of a section or department with responsibility for results, including costs, methods and staffing.
- Manages activities of two or more sections or departments.
- Manages local authority engagements.
- Active engagement with the industry forum.
You are a part of
You are part of Growth Region Regulatory team responsible for APAC Zone. Reporting line of this position is to Head of RA Growth Region. You will have exposure to a multitude of medical devices, Business groups and sites and workflow solutions and services. This position partners with business leaders, marketing, quality, and legal among other functional areas where you will guide the related stakeholders in application of all applicable regulatory requirements, ensuring gap analysis, regulatory assessment and impact for a successful regulatory submission and approval in each impacted country.
To succeed in this role, you should have the following skills and experience
- Strong knowledge of appropriate regional and global medical device regulations, requirements and standards.
- 10 years of experience in medical device industry in APAC
- Strong relationship and engagement with local authorities across APAC Zone.
- Experience in assembling the technical documentation files or design dossiers
- Strong project management skills
- Has wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways
- Ability to interpret applicable regulations to ensure compliance in a changing regulatory landscape
- Ability to work nimbly, innovative approach to problem solving
- Ability to work in a matrix organization and being agile
- Strong organizational skills, ability to work on multiple projects, and work effectively in a demanding, time-sensitive environment.
- Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers.
- Exercises supervision in terms of costs, methods, and staffing.
