Senior Manager, Raqa

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Senior RAQA Manager, JAPAC
Overview
Managing pre and post-market Regulatory Affairs for Japan, Asia and Pacific Ocean (JAPAC) region for LMS products.
Support role to the growth and the further acceleration of product portfolio development (NPI) of the LMS Medical Business Unit (BU).

**Responsibilities**:
Develops and oversees advanced and aggressive RA strategies for JAPAC, in close cooperation with the local RA experts, Selling Units / Channel Partners and the LMS RA/QA VP.
Manages local RA experts in China and Korea; establishes objectives in alignment with the overall LMS RA/QA goals.
Provides support/coordination for post-market JAPAC regulatory activities (e.g. regulatory watch, recall) in close collaboration with the LMS RA/QA BU teams.
Implements global Regulatory requirements into product development and ensure that documentation is adequate (e.g. CFR21 part 11 compliance).
Supports the R&D team in process development
Collaborate with Product management and R&D regarding e.g. Quality Processes, requirement engineering, Verification and Validation of Software and the relevant Products.
Supports quality strategies for development projects, support RA/QA members of these development projects in close cooperation with R&D and Product Management.
Ensure the department operates under the Quality Management System and Environment, Health & Safety (EHS) requirements and to address EHS issues raised by associates
**Requirements**:
Professional Experience
R elevant expertise in Quality Systems within demonstrated knowledge of ISO9001, ISO13485 and US 21CFR820.
Track record in increasing RA or QA positions with demonstrated problem solving and continuous improvement skills
Proven expertise and knowledge of JAPAC premarket regulatory requirements for Class I and II medical devices (or higher). IVD regulatory experience nice to have. China regulatory knowledge is mandatory. Regulatory knowledge of other JAPAC countries (e.g., Japan, Korea, India, Australia) would be preferred.

b) Education
Minimum Bachelor’s degree in Engineering or Life Sciences. Advanced degree preferred.

c) Language
Fluent in both written and spoken English
Language proficiency in German, Chinese or Japanese is nice to have to liaise with the native speaking associates.

d) Travel (required estimated % of time)
Must have ability to travel internationally for up to 20%

e) Other
Excellent communicational skills; an open, responsive and confident/assertive individual
Proven leadership skills with the ability to take the lead in a team, manage by influence and also function as a team player
Excellent attention to detail and ability to deal with complexity, associated with excellent English writing skills.
Development oriented person with focus on continuous improvement
Takes ownership and is accountable
Engaged and committed

WHAT WE OFFER
Equal pay is a given for us.
Learn all there is about Kaizen, PSP's and Muda as part of our Danaher Business System (DBS) trainings - if you believe in continuous improvement like us
We have no room for prejudices and stereotypes. We promote equal opportunities, diversity and inclusion.
We offer a balance between support and autonomy to achieve your own goals in an international environment

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When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

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