Sr Sup Regulatory Affairs - Medtech - Orthopedics

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 https://www.jnj.com

Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Affairs

Job Category:
People Leader

All Job Posting Locations:
São Paulo, Brazil

Job Description:

Coordinates and ensures proper submission and approvals for market licenses including new registrations, changes and timely renewals, and establishment registrations, organizing and balancing a multitude of projects simultaneously.

At this role, the professional will:


* Lead the team elaborating goals and objectives, supporting development plan and performing performance evaluations.


* Coordinate the work of RA Specialists to ensure submission is done properly and in timely manner and systems are being updated correctly.


* Coordinate and guide regulatory strategy of changes, new registrations and renewals, elaborating mitigation plans and serving as a technical expert within job function.


* Coordinate activities to obtain or update establishment registration licenses.


* Coordinate with regional team on product submissions schedules, prioritization, and pipeline management and escalate critical situations.


* Act as a point of contact for stakeholders to support business plans and regulatory needs.


* Coordinate implementation of new regulations.


* Lead or support a multitude of projects as representative of the subject/country.


* Guide the review of promotional materials according to MOH regulation.


* Lead or participate of meetings with Trade Associations and Health Authority.


* Scan and influence the external environment.


* Represent the area in internal and external audits.


* Elaborate and review procedures of the area.


* Coordinate team meetings and elaborate agenda and minutes.


* Coordinate acquisitions and divestitures.


* Manage quality issues.


* Act as point of contact for change controls.


* Coordinate compulsory certification and GMP activities.


* Selects and manages external consulting services to prepare files in same conditions than internal procedures as needed.


* Act as legal representative of the company.

It is expected that this person is solid in:


* knowledge of Local & International Regulation and Processes of Medical Devices,


* analytical capability, 


* problem solving skills, 


* planning, organizing and prioritization skills, 


* communicates clearly, succinctly and effectively, 


* understands the...