Global Surgery GS Reg Affairs Support Associate

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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.

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GS Global Surgery Regulatory International Markets Support Associate (PG24)

Reimagine the possibilities at Johnson and Johnson Global Services! We live this motto every day by creating game-changing business solutions for the worlds largest and most broadly-based healthcare company.

As a member of our Global Services team you will have exclusive access to a network of professionals located in over 60 countries. This new network will help you build on your current skills and explore opportunities to grow your career in J&J.

At J&J Global Services we value ideas for innovation and improvement and are committed to diversity and inclusion. Together we will reimagine business processes to become more effective more efficient and improve customer experience. We are proud to be an equal opportunity employer. The Global Services organization provides best-in-class cost-effective services and compliancein a J&J wayto our Operating Companies around the world.

This role will be part of the Global Services in the Strategic Solutions and Commercial Services (SCS) function supporting the Global Surgery MedTech Regulatory Affairs team- particularly the Reconstructive and Aesthetics business.

Johnson & Johnson MedTech Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies orthopedic and interventional solutions we aspire to improve and enhance medical care for people worldwide. Together we are working to shape the future of health through differentiated products and services.

Fueled by innovation at the intersection of biology and technology were 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 Global Surgery Regulatory Affairs (RA) are responsible for regulatory activities for the J&J Surgery portfolio.

GS Global Surgery Regulatory International Markets Support

Key Responsibilities:

• Gather interpret and confirm international market regulatory requirements and country-specific needs with local RA stakeholders.

• Prepare compile and deliver the required regulatory documents/response packages to support submissions and in-country requests.

• Identify troubleshoot and remove roadblocks (e.g. missing inputs unclear requirements document gaps) by coordinating with cross-functional partners.

• Communicate status clarifications and issue escalations in a timely manner to ensure on-time delivery and stakeholder alignment.

• Build and maintain foundational knowledge of RA document types and their purpose; apply basic RA experience to ensure accuracy and compliance.

• Complete product-specific training and continuously develop product knowledge to support accurate document preparation and responses.

• Document current workflows and over time draft or update standard operating procedures/work instructions to improve consistency and efficiency.

• Complete process training to support accurate document preparation

• Ensure adherence to established metrics & targets

• Support any other related work to drive regulatory compliance and team effectiveness; helping build a high performing team culture and continue to improve ways of working

Required Skills:

• Follow standard work instructions and templates with high accuracy; validate deviations with the appropriate team or expert before proceeding.

• Strong Communication skills. Can communicate clearly in English (written and verbal) to clarify requirements and resolve queries with local Regulatory Affairs stakeholders across multiple markets.

• Organize version-control create and maintain required work instructions and documentations to ensure completeness accuracy and audit readiness.

• Coordinate work across multiple requests and timelines; track tasks dependencies and deliverables to support on-time completion.

• Demonstrate basic awareness of international trade/logistics concepts that may impact regulatory documentation and market distribution.

• Learn new systems and tools quickly; troubleshoot routine issues and seek support when needed.

• Use professional business language in stakeholder interactions; additional language capability is an advantage for multi-market support.

• Demonstrate critical thinking and problem-solving mindset by identifying root causes proposing options and driving closure with the right partners.

• Ability to translate requirements into solutions and ability to challenge the status quo to adherence to requirements

• Ability to challenge and validate where request is driven by regulatory requirements or historical ways of working.

• Work confidently in digital environments (e.g. SharePoint/Teams and document management tools) while maintaining data integrity and confidentiality.

Qualifications & Background:

Education

• A minimum of a bachelors degree is required

Other Requirements

• 3 years of professional experience preferably within the medical device surgical or healthcare industry

• Operate with discipline and sense of urgency.

• Strong learning agility

• Leadership and Team-oriented mindset.

• Experience on Regulatory Quality or Clinical in Medical device or pharmaceutical fields

• Ability to work effectively in a cross-functional environment and build support across a complex set of stakeholders.

• Strong attention to detail and a commitment to compliance and data integrity

• Ability to execute plans with attention to detail.

Preferred

• Experience in a multinational corporation is desirable.

Working Hours:8/9am SGT 5/6pm Manila Time

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin or protected veteran status and will not be discriminated against on the basis of disability.

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