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The Manager, Regulatory Affairs leads a team of individual contributors and is accountable for conducting effective performance management. The manager is also responsible for regulatory strategies that support the execution of the Wound Closure and Healing portfolio strategy and regularizing the Brazilian manufactured products, ensuring compliance to local and international regulations and ensuring business continuity through the maintenance of compliant and accurate registrations / sanitary licenses. The individual will have end to end responsibility for maintaining existing products in key markets and launch of new/improved products in alignment with portfolio strategy. The Manger will be strategic by considering new and changing regulatory requirements to identify the most effective and efficient strategies for compliance. This position is also responsible for providing direction and leadership to RA team members in the development and execution of global regulatory strategies and processes to ensure timely registration of Wound Closure and Healing products globally.

DUTIES & RESPONSIBILITIES*

Under limited supervision and general direction in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Coordinates the production and compilation of the required documentation to legally regulate the sanitary registration of the products manufactured in Brazil, in the countries of Latin America (LATAM), Asia, Europe, Africa and USA, and when applicable, carry out the registers directly in the countries of interest.

• Ensure that documentation of products manufactured by Brazil is available when and where customers need it, providing guidance to technical areas, preparing documents in compliance with regulatory requirements, to support both local and international registration, and marketing of the products. products in the public market (biddings) and in the private sector.

• Participate in key projects of the SJDC site, delivering strategies and regulatory results within the agreed time frame in the project schedule.

• Identify and anticipate changes in the national and international health regulatory environment of interest and impact on the business or products of the SJDC site to support the implementation of new or changed health regulations / standards to ensure that the site's products, processes, practices and procedures of SJDC are in compliance therewith.

• Keep updated under the regulatory sanitary aspect, procedures and approvals in the systems of use by the site of SJDC, such as EtQ, Barcode, ADAPTIV, and MDRiM which includes the Preliminary and Final Regulatory assessment, if applicable.

• Interact, establish and maintain communication with health authorities and notified bodies, such as ANVISA, BSI, SABS, TGA and others directly related to the activities of the SJDC site.

• Participate as representative of the Company in national or international forums for discussion and creation of sanitary standards and regulations, of business interest, to contribute positively to the Brazilian regulatory environment.

• Maintain up-to-date licenses / certificates / health authorizations required for the SJC site operations.

• Support inspections, audits, field actions, site-related techno-surveillance, and products manufactured by SJDC.

• Establish strong connections and collaboration with business partners at SJDC and ETHICON USA, such as quality, legal, packaging, manufacturing, market, regulatory affairs.

• Ensure subordinates follow all company guidelines related to Environmental, Health, and Safety practices, and that all resources needed are available and in good condition, if applicable.

• Empower team to act with speed, agility, and accountability.

EXPERIENCE AND EDUCATION*

• Degree in Pharmacy or related areas.

• A minimum of 8 years of working in a Regulatory Affairs preparing submissions for complex devices or other product categories.

· Fluent English.

• Spanish desirable.

· Active affiliation with CRF-SP, able to assume a technical responsible role

• Multi country experience desirable.

• Experience 1 - 2 years direct management.

• Knowledge of regulatory environment such as Brazilian Directives, Medical Devices Directive (MDD), FDA regulations and others

• Analytical problem-solving skills

• Ability to partner within the team and across teams

• Strong communication and presentation skills

• Critical thinking and ability to partner with key stakeholders

· Strong interpersonal and analytical skills to understand technical data/information

LOCATION AND TRAVEL REQUIREMENTS

• Position based in Sao Jose dos Campos or Sao Paulo
• Occasional travel for domestic and/or international territories.