Regulatory Affairs Policy Senior Manager LATAM - J&J do Brasil Indústria e Comércio de Produtos para Saúde Ltda. - West Chester, PA

Johnson & Johnson’s Medical Devices Division is currently recruiting for an Regulatory Affairs Policy Senior Manager LATAM, in support of the Regulatory Affairs Group to be based at a J&J facility in one of the following regions: North America or LATAM.

The Global Surgery and Global Orthopedic Regulatory Affairs Centers of Excellence has recently integrated to support all operating companies under Johnson & Johnson’s Medical Devices Division.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The Associate Director, MD Latin America Policy Intelligence, serves as the MD RA leader monitoring the Latin American (LATAM) regulatory landscape for changing regulatory requirements and opportunities. This role is responsible for communicating dynamic regulatory information into the Global Regulatory Policy & Intelligence organization.

MD RA LATAM Policy Intelligence leader is responsible for identifying and acting on opportunities for regulatory policy improvement across Latin American HAs; acting as the primary driver in prioritizing and implementing regulatory policy influencing initiatives impacting LATAM; and communicating dynamic regulatory policy initiatives into the Global Policy Innovation.

In this role, the Sr Manager will proactively monitor LATAM HA activity and regulatory policy opportunities through systematic review of local, regional and global regulatory needs and requirements impacting J&J’s MD business. The Senior Manager will assess changes in LATAM regulatory policy and analyze the impact on MD RA and individual BUs. Also will be responsible for identifying, cultivating, and nurturing relationships with key health authority leaders and other organizations necessary to proactively shape LATAM regulatory policy. S/he contributes to the development of global MD RA strategy for capitalizing on regulatory policy opportunities and needs.

This role provides consistent and systematic information to MD RA Policy and Intelligence Leadership Team and MD business leaders on LATAM regulatory policy opportunities, needs, and initiatives. The Sr manages J&J responses to proposed LATAM policy change and informs RA leaders of policy change.

Qualifications

A minimum of a Bachelor’s Degree or equivalent with experience in regulatory policy, public policy, government relations, or regulatory affairs leadership within the medical devices or related (healthcare, pharmaceutical) industry is required. The ideal candidate will have strong political acumen, and demonstrated regulatory or policy skills.

Knowledge of global regulatory requirements, processes, and health authorities across the medical device field is required. Ability to articulate regulatory policies and their implications for multiple audiences (internal and external) is required. S/he will work effectively with internal/external corporate regulatory groups, health authorities, and trade associations to efficiently shape global regulatory policy. Strategic thinking and ability to partner with key external health authorities stakeholders at senior levels.

This role will require approximately 25% domestic and international travel.

Primary Location

Argentina–

Other Locations

Latin America-Chile, Latin America-Brazil, Latin America-Colombia, Latin America-Argentina, Latin America-Mexico

Organization

J&J do Brasil Indústria e Comércio de Produtos para Saúde Ltda. (7600)

Job Function

Regulatory Affairs