[MedTech] Sr. Regulatory Affairs Specialist (Contractor)

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Seoul, Korea, Republic of

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for Sr. RA Specialist to be in Seoul.

 

Position Summary:

Coordinates, compiles, and submits applications of new products or changes to the approved products to the regulatory agencies. Ensures compliance with regulatory agency regulations and interpretations. Prepares responses to regulatory agencies' questions and other correspondence. Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines. Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides. Provides solutions to a variety of problems of moderate scope and complexity. Organizes and maintains reporting schedules of new product registration, changes in products, projects, etc.

You will be responsible for:

Functional and Technical Competencies

Prepares, submits, and monitors applications of new products, changes, renewals in approved products, and KGMP.

Applies knowledge in regulations and characteristics of products to prepare compliant regulatory strategies and to assess regulatory impact on products as product life-cycle management.

Interacts with regulatory agency personnel in order to expedite approval applications and to resolve regulatory matters with limited supervision.

Follows up of mandatory requirements for registration: local certificates, importation of samples, local testing, etc. with limited supervision.

Ensures Korean label contents and approves the final Korean label artwork.

Researches and consolidates regulatory requirements and actively communicates with the supervisor and the manager.

Provides training and limited supervision of contract resources, as needed.

Supports and contributes to team, company, regional, global, cross-sector projects.

Shares best practices and learnings with the team in terms of RA processes and templates, product registration, projects, etc.

Conforms regulatory compliance including but not limited to promotional material review and regulatory impact assessment.

Leverages experience and learnings from the past to make reasonable decisions in the challenging situations.

Understands business environment and business strategies and develops effective and results-oriented regulatory strategic plans that are in line with business objectives. Manages specific project steps to meet milestones independently or with limited supervision.

Understands trends in the healthcare environment, changes in external marketplace, and competitors’ tendency and the influence of social, economic, and political factors on business and regulatory environment.

 

Leadership Competencies

Effectively manages priorities and strongly collaborates with stakeholders to make the best possible decision. Consistently manages large amount of changing, complex, ambiguous information and makes reasonable decisions in a timely manner.

Engages with external stakeholders and demonstrates conviction, proactivity, and persistence especially when influencing others and overcoming resistance. Creates compelling positions in negotiations that build support and consensus with key stakeholders. Builds and leverages internal and external networks with colleagues, cross-functional partners, and industry contacts to identify opportunities and open communication channels.

Creates and delivers verbal and written communication with highlighting the most pertinent information for targeted stakeholders. Supports stakeholders to take actions if needed.

Acts with speed, agility and accountability in the decision making and balances short and long-term decisions and activities. Demonstrates an enterprise-wide mindset.

Experiments and learns from trying new approaches and applying the new ideas from insights

Qualifications / Requirements:

A minimum Bachelor’s degree

Minimum 3 years of experience in Regulatory Affairs, with medical device RA experience required (job title may vary depending on the candidate’s level of experience).

Understanding in regulatory requirements, laws, standards, and environment

The incumbent must have the ability to work effectively with limited supervision and process requests/work within required timeframes

Strong communication and interpersonal skills

Experience in a multi-national or regional company is preferred

Fluent in both verbal and written Korean and English

Legal Entity

MedTech

Job Type

Fixed Term(1 year)

Application Documents

Free-form resume AND cover letter is required (in Korean or English).

Application Deadline

Open until the position is filled.

Notes

Preference will be given to individuals subject to national veterans’ benefits and persons with disabilities upon submission of relevant documents as per applicable laws.

Only candidates who pass the resume screening will be notified individually. However, notifications may be delayed due to company circumstances.

If any false information is found in the application documents, the hiring may be canceled even after the offer is confirmed, and future applications may be restricted.

Submitted documents will not be returned and will be deleted upon request.

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Behavior, Business Writing, Communication, Confidentiality, Data Reporting, Detail-Oriented, Legal Support, Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Teamwork