Senior Regulatory Affairs Program Lead

**Job Function**:
Regulatory Affairs Group
**Job Sub Function**:
Regulatory Affairs
**Job Category**:
Professional
**All Job Posting Locations**:
São José dos Campos, São Paulo, Brazil, São Paulo, Brazil
**JOB SUMMARY**
Experienced individual contributor, who operates with mínimal supervision and has end to end responsibility for the life cycle maintenance and new product development launches within the Wound Closure and Healing portfolio. The Senior Regulatory Affairs Program Lead provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches. The individual leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers. He/she guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials. The Senior RA Program Lead helps to define data and information needed for regulatory approvals in conjunction with crossfunctional product development teams. The role assists in the identification and development of best practices for Regulatory Affairs processes
**DUTIES & RESPONSIBILITIES**
- Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
- Ensures compliance with regulatory agency regulations and interpretations. Gathers and assembles information necessary for submissions in accordance with regulations and relevant standards.
- Provides solutions to extreme complex problems in which data analysis requires an evaluation of intangible variables.
- Utilizes strategic regulatory thinking along with technical expertise to implement regulatory strategies for product clearances and approvals
- When required, manages MDR updates in coordination with MDR execution and implement changes globally
- Reviews various changes made to existing products to assess the impact on safety and effectiveness and determine appropriate RA pathway for implementation
- Review advertisement and promotional product material to ensure compliance to regulations.
- Partners with EU and Regional leaders to monitor the regulatory environment globally and provide assessments of the impact of new and changing regulations on the company's portfolio of products and help drive strategies to achieve a competitive advantage and benefit for the patients
- Works with team members and commercial partners to oversee the regulatory aspects of new products launches
- Independently makes decisions regarding work processes or operational plans and schedules
- Possesses excellent written and verbal communication skills
- Provide Regulatory Affairs support during internal and external audits
- Assist in the development of best practices for Regulatory affairs processes and systems
- Responsible for communicating business related issues or opportunities to next management level - Performs other duties assigned as needed.
**EXPERIENCE AND EDUCATION**
- 4-6 years of Medical Device industry or medical field experience and a bachelor’s or master’s degree is preferred
- Science, Medicine, Pharmacology, Medical-Engineering or Engineering, or equivalent education
- Experience with global medical device regulations
- Expert EU Medical Device Regulations (or equivalent)
**REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS**
- Working knowledge of Global key market Medical Device regulations
- Expert on EU Medical Device Regulations (or equivalent)
- Project Management skills (Leading Projects)
- Analytical problem-solving skills
- Proactively addressing challenges o Science or engineering background.
- Verbal and written communication skills
- Able to work in a team o Able to work in a global network
- Able to present to internal and external audiences
- Language skills: Portuguese and English (required), Spanish (desired)

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