Project Manager - Medical Devices

Location:
Seoul, South Korea
Business:
Supply Chain & Product Assurance
Position type:
Full Time
Contract type:
Permanent Employee
Job ID:
4724
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Overview

About us

We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence.

As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations.

About SCPA

We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. 

About the role

The Project Manager is a key role in the MDR project. The Project Manager has the overall responsibility to ensure that the project is performed according to the Certification Agreement and the quality management system requirements, ensure a good internal communication with all resources and units involved in the project to have a smooth and efficient execution of the project, and to ensure a good cooperation and communication with the customer.

Responsibilities:

  • Ensures that the audit package is upload in the Production system.
  • Recommend certification based on the QMS audit and prepares recommendation for certification, including the draft certificate (assisted by the assessor for MDR certificate), and sends audit and assessment documentation and reports to technical review.
  • Communicates with Planner and/or person in charge of Sales if any changes in Certification Proposal or agreement must be initiated.
  • Communicates with Certification Manager, MDSAP Technical Manager for MDSAP Processes, and/or Global Clinical Affairs Manager if issues related to safety and performance of the medical device is identified during the audit/assessment, and the need of suspension/withdrawal of the certificate must be considered.
  • Coordinate and lead planning sessions for project development and execution
  • Manage staffing and other resources needs to maximize potential for successful execution of projects
  • Coordinate within medical services delivery by working closely with the Global Certification Unit(GCU) and other units/managers
  • Define project objectives and scope, identifying involvement of internal and external stakeholders
  • Conduct risk analysis to reduce unforeseen obstacles and costs
  • Create detailed schedule, project parameters, and budget expectations
  • Create a complete project plan with timelines from technical file submission to certificate issuance
  • Conduct periodic scope, schedule, and cost reviews using industry best practices, to identify needed adjustments
  • Measure project performance and progress throughout campaign execution
  • Manage client and other stakeholder expectations to maintain productive and engaged relationships
  • Ensure professional and responsive customer support, leading to high customer satisfaction and maintaining a strong market reputation
  • Document project activities, obstacles, costs, and results
  • Assist the planning & scheduling in accurate scheduling and optimal resource utilization
  • Delegate project activities and duties in accordance with team members’ strengths and experience
  • Provide summarized project plan documentation to departmental managers, clients, and other stakeholders as needed
  • Act as single point contact for the customer for all project related activities
  • Engage in continual learning to remain abreast of industry best practices, new technologies, and emerging standards
  • Collaborate with and lead teams to deliver results on schedule and within budget limits
  • Maintain medical services to meet the requirements from Notified Bodies(NB) and accreditation standards
  • Cooperate with the finance team for forecast preparation, analysis, and support in invoicing processes
  • Assist in handling complaint management to promptly address issues and uphold service quality
  • Execute other role duties as assigned

What we offer
  • Flexible work schedule with hybrid/selective working opportunities for better work-life balance
  • Generous paid leaves (annual paid leave, special paid leave)
  • Pension and insurance policies (corporate life insurance, local group insurance, travel insurance, retirement pension)
  • Additional benefits (meal allowance, transportation allowance, holiday bonus, tuition assistance for children, annual medical check-up, long service awards)
  • Competitive salary along with profit share
DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity.

About you

Required:

  • Minimum of 10 years of relevant experience in a similar role, with a preference for experience within the medical industry
  • University degree or equivalent qualification; technical background is a plus
  • Fluent in English is a must
  • Demonstrated experience in managing complex projects involving multiple stakeholders
  • Strong client communication skills and proven ability to build and maintain excellent client relationships
  • Excellent organizational, coordination, and project management abilities

Preferred:

  • Self-motivated with a positive and proactive attitude.

Benefits

Profit Share

You’ll be part of our global profit share scheme that means we all share in our success as a business. If we profit, so do you. This will be part of our Total Compensation approach each year and depends on our year-end results.

Insurance

Taking care of you with travel, life, and accident insurance.

Pension Schemes

We care about your long-term financial security and prioritize pension and retirement benefits to reflect our caring values.

Professional Development

We believe in the 70/20/10 learning model, where 70% of your learning comes from performing your everyday tasks and working on different projects, new areas and initiatives to gain new skills. 20% from working with others and mentoring and the rest from formal education.

Hybrid Working

Adapting to the changing world of work around the world.

Purpose-led organization

You become part of a world-leading company where we know and live our purpose; to safeguard life, property, and the environment, with the opportunity to tackle global change through your work.

Supportive and caring culture

We offer opportunities to connect through social and professional networks. Our largest community CONNECT, organizes after-work events and informal meetings throughout the year.

Attractive rewards

We focus on work/life balance and offer employees flexible working hours and workplace, annual vacation allowance, competitive pension, insurance, and a global profit share scheme.

Diversity, Equity and Inclusion

At DNV, our commitment to Diversity, Equity, and Inclusion is not only an ethical choice, but also a business decision.

Diversity, fairness, and a sense of belonging are a source of strength for our people, our business, and our customers, and help us to deliver on our purpose, vision, and values.

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Working here

Since 1864 we’ve been dedicated to safeguarding life, property and the environment. Today we remain at the forefront of new technologies and techniques to help our customers transform for a more sustainable future.

At DNV you can expect to deliver career and industry defining work. You’ll be given the time to build your network, the resources to support your development, and the freedom to satisfy your curiosity and desire to learn.

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Application Process

FAQs

Welcome to our Frequently Asked Questions page. We’ve put together answers to the questions we’re asked most often to help you find the information you need quickly and easily. Whether you're curious about our recruitment process, benefits or career growth and development, you should find the information below.

How can I find job openings that fit my skills and interests?

Explore our official job search page where you can use filters such as job type, location, and department to find roles that best match your qualifications and career aspirations.

What’s your application process like?

You can apply directly through our careers page by submitting your CV and any other documents we require (i.e. university diplomas/transcripts; visas; previous employment reference letters). Make sure your application is fully completed, and you tailor it to the specific job listing. 

Is your recruitment process designed to be inclusive and accessible?

Yes, it is. We're an equal opportunities employer and welcome applications from all candidates. We’re happy to support your need for any adjustments during the application and hiring process. Share the details of what you need within your application.

What types of interviews might I undergo?

Depending on your role, our interview process may include initial phone screenings, video conferences, and in-person interviews, focusing on both your technical abilities and our shared values. You can ask your recruiter specifically about the interview process for your role. 

How long does the hiring process typically take from application to decision?

The timeline can vary but we make every effort to reply to each candidate as soon as possible and keep everyone up-to-date with where they are in the recruitment process.

How do I know if a recruitment contact is legitimately from your company?

Official communication will come from our verified company email addresses. Carefully check any suspicious looking emails and if you have any doubts, don’t engage.

Are there any fees involved in your recruitment process?

No, we do not charge any fees at any stage of our recruitment process. All applications and interviews are free of charge, we will never ask you to pay any fees or make any payments – please be wary of any requests for payment as these are likely scams.

What should I do if I suspect a job scam?

If you encounter suspicious job postings or recruitment practices, do not provide personal information and contact your recruiter as soon as possible. We take these matters seriously. We will never ask you to pay any fees or make any payments part of our recruitment process.

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Disclaimer

Please beware of recruitment scams that pretend to be from DNV or its employees. We will never ask you to pay any fees or make any payments as part of our recruitment process.