Regulatory Affairs & QA Manager

The role will be responsible for achieving corporate

objectives and effectively ensuring that agreed strategies are

implemented. Accountable for all regional and local regulations for

the statutory compliance of all regulatory and QA affairs

activities of the Company.

A key requirement

will be to balance internal hands-on execution priorities with

regional strategic alignment, and at the same time, be able to

navigate the current complex policy

environment.

Contribute with regulatory skills

to the innovation of products and services focusing on improving

patient's outcome. The role requires strong understanding of the

regional business environment, work in collaboration with

regulatory / Q&R team in the markets, strong interaction with

corporate / manufacturing RA teams on Regulatory Affairs

matters.

To represent Terumo and participate in

industry associations (e.g. APACMed, MTAA, etc.) to create Terumo

voice of advocacy.

Key

Functions / Responsibilities

Strategic

Planning :

• Developing and implementing regional

regulatory strategies and processes to support the timely

registration of new products, major changes and life cycle

management.

on ways to resolve issues related to regulatory premarket

activities and promote strong partnerships to

drive

implementation and resolution.

Terumo in local or regional standards committees, industry

associations, national competent authorities influencing future

regulations and standards and deploy them in the

organization

by influencing product registration, prioritizing product

registration, mitigate potential regulatory approval risks

based

on regulations, standards, country-specific issues

or other unique characteristics

communication between global, TAP RA to ensure implementation

of

all strategic plans.

Operation

Efficiency :

in the manufacturing units and CRAO and

regulatory affairs

teams in the countries under the scope to ensure

optimal,

efficient and compliant registration and QA

reporting.

with local and international

requirements to ensure Terumo

products are registered on time or life cycle

management

in the markets are in scope of responsibility, and post

marketing

surveillance risks are minimised.

Responsible for Regulatory monitoring and analysis of new or

updated local

legislation and for assuring in-time

registration in the local market (country).

regulatory plan and a labelling plan (when needed) to

ensure

consistency and guidance to the market introduction

projects.

create a cogent process of

documents / data management /

storage and / or document flow which is easy and

efficient

for access to relevant stakeholders.

in-country RA teams to ensure product compliance by executing

the

annual regulatory plan and reviewing all relevant

compliance evidence.

teams to ensure timely, effective and efficient

transition

to new requirements.

ensure compliance on RA&QA matters

creation and use of automated / visual dashboards and

scorecards

for as many business and function process

tracks

Talent Development and

Management :

the in-country regulatory affairs team members.

knowledge and guide and mentor others about regulatory best

practices

and registration standards for regulatory

approvals and post-market needs.

actively, plan, develop and assess learning needs of

key

Associates, with specific focus on current and future

business needs of the

organization

personal network within the relevant talent community and take

personal

accountability in attracting, developing,

mentoring, retaining and growing best

regulatory affairs

talent in the region

with educational programs about RA knowledge enhancement, Terumo

group products, and BU marketing strategy.

yearly Asia RA meeting for development and planning of RA

yearly

strategy plans.

Deliver through

a hands-on management style :

field or floor), Gembutsu (seeing actual products in

R&D,

production and use), and Genjitsu (facing

reality) are fundamental Terumo /

Japanese business

traits. it is important for this role to demonstrate

this.

management. Support teams in

execution of product

requirements and registration.

Champion of

Terumo culture :

close-knit, collaborative and supportive team within

the

region. Understand BUs operations and priorities, work

cooperatively with others

across the organization to

achieve shared objectives to support

business

requirements.

viewing each issue from a "Gemba" perspective in order

to

find the optimal solution. Pursue excellence in product quality,

from product

supply to customer care.

efforts on continuous improvement; has a knack for identifying and

seizing

opportunities for synergy and integration. Figure

out the process necessary to get

things

done

Education &

Experience :

degree / s. (Medical / biomedical background)

experience in Regulatory Affairs Medical Device (class 1, 2 and 3)

is a must

experience in Regulatory Affairs in APAC Team management

experience.

transcribe dossier from Japanese to English

Key

Technical / Functional Competencies :

of regulatory concepts and standards

product development and clinical investigation

regarded personal work ethics and character

Management. People skills extraordinaire, people empathy &

compassion

communication style.

understanding (an exception can be made for a highly talented

candidate)