Regulatory Affairs Specialist

**Regulatory affairs specialist**:
At Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose: to profoundly change the trajectory of health for humanity.

Diversity & Inclusion are essential to continue building our history of groundbreaking and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.

When You Join Johnson & Johnson, Your Next Move Could Mean Our Next Breakthrough

At Johnson & Johnson Medical Devices Companies, we are using our breath, scale and experience to reinvent the way healthcare is delivered and to help people live longer, healthier lives.

In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics and interventional solutions with the big ideas of others to craft and deliver doctor and patient-centric products and solutions.

We are hiring the best talent for **Regulary Affairs Specialist** to be located in **Lima** (Relocation Not Applicable / Applicable).

**Purpose**:
Serve as a technical professional on documentation required for submissions for multiple business units in the Medical Device sector of Johnson & Johnson

**Key Responsibilities**:

- Actively participation and timely delivery results in RA teams to achieve common goals or attend common strategies.
- Prepares common registration dossiers for new products' introduction, new product development, product changes and renewals.
- Reviews and assesses documentation to ensure accurate interpretation of country regulations.
- Supervise and analyze country requirements to identify trends/changes in regulation.
- Consults with other partners within the organization regarding submission requirements and standards to facilitate efficient processing by health authorities in multiple countries.
- Integrates and completes the Regulatory Affairs strategies. Accountable for the achievement of business goals and objectives, based on priorities and considering benefits/risks.
- Consistently handles large amounts of changing, sophisticated, and/or ambiguous information
- Assists in the development of standard methodologies for Regulatory Affairs processes
- Support change assessments implementations by planning schedules for regulatory deliverables, supervising submissions through completion.
- Coordinate information on several projects simultaneously.
- Ensures compliance with governmental regulations and interpretations.

**Qualifications**
**Qualifications and Requirements**:

- A Bachelor’s Degree or career on process in Engineering, Pharmacy or other life science: Can be a person with related experience and/or training or equivalent combination of education and experience.. English (intermediate) - local language (Spanish)
- Sophisticated PC skills
- Must have 1-3 years experience at least working in Regulatory Environment (and/or training or equivalent combination of education and experience), preparing submissions for sophisticated devices and a successful track record. Desirable experience in Medical Devices. Pharma background is acceptable.
- Knowledge in Peruvian Regulation and Processes; previous experience in dossier creation desirable.
- Analytical capability
- Prioritizes work to meet deadlines
- Communicates clearly, succinctly, and optimally.
- Planning and Organizing skills
- Understands the importance of the adherence to compliance

**Primary Location**
Peru-Lima-Lima
- **Organization**
Johnson & Johnson del Peru S.A. (7757)
**Job Function**
Regulatory Affairs
**Requisition ID**
2206015930W