Are you a RA Specialist passionate about RA planning and strategy for manageable regulatory risks? If so, this opportunity could be for you! Join us at B. Braun Korea, a leader in the medical devices industry, where your skills and experience will be recognized and celebrated. Take the next step in your career with us and help shape the future of healthcare!
As a RA Specialist at B. Braun you will play a vital role in….
*Please note that this is a fixed term 1 year contract role*
- Manage regulatory affairs projects under his/her responsibilities agreed with RA Manager and Head of division
- Provide short/mid-term RA project plans to align with company strategy
- Ensure to complete regulatory affairs projects in timely manner according to milestone as agreed with RA manager and Head of division.
- Ensure product life cycle management and post approval change controls are done as required for the projects under his/her responsibilities.
- Provide regular assessment of post approval change control plan to mitigate the risk and prioritize the RA projects.
- Ensure planned regulatory risk management is done in timely manner
- Establish and maintain collaborative relationship with CoE GRA and internal stakeholders, as well as external stakeholders.
- Manage budget for responsible regulatory projects.
- Provide regular monitoring and business impact analysis of regulatory environment changes and share them with wider group as required to ensure alignment.
What you will bring to the team:
- Timely completion of responsible product registration, line extensions and related regulatory activities
- RA budget for responsible regulatory projects managed within the agreed budget plan
- Minimum 1-5 years relevant experience in medical device industry
- Multinational company experiences preferred
- Experience of leading project preferred
- Effective and clear communication and sound interpersonal skills
- Ability for problem solving and decision making
- Sound knowledge of relevant international and Korean regulations
- Good command of spoken and written English
- Ability to work under competing priorities and to work cross functionally
- Good initiative and self-motivated
REQUIRED B. Braun Competencies
- Learn actively
- Deliver Performance and Results
- Act with Customer Focus
- Influence Positively
- Drive Ideas and Change
- Cooperate Constructively
- Appreciate and Include Different Perspectives
- Foster Equality
- Show Empathy
Benefits
- Flexible work arrangements and option to work from home.
- Flexible Benefit Allowance (Welfare Card)
- Support for communication expenses.
- Birthday gift certificates.
- Provision of health check-ups.
- Congratulatory expenses and vacations.
- Children's tuition (high school, university)
- Long service awards.
What’s next?
Once you click on the link to Apply, you will be directed to update your personal information and submit your CV. Our Talent Acquisition team will carefully review your application, and if you pass the CV screening you will be invited for the first interview. We ask you to conduct two interviews, one in person and one remotely. If you stand out and meet our requirements, we will present you with an offer and guide you through our seamless onboarding process. Join us and be part of something extraordinary!
We appreciate different perspectives, thoughts, experiences and backgrounds. By strengthening an appreciative, inclusive, respectful and equal working environment, we create a culture in which all our employees feel free to be who they are. To find out more about our commitment to diversity click here
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To find out more about B. Braun Korea just click here