Regulatory Affairs Manager

DE&I Statement

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential.

At Johnson & Johnson, we all belong.

We are searching for Regulatory Affairs Specialist the best talent for to be in Bogotá, Medellín, Cali, Cartagena, Barranquilla
- Colombia.

Purpose: To ensure effective regulatory compliance and strategic oversight in the submission and approval processes of medical devices and related products, promoting collaboration across functional areas, and maintaining communication with regulatory agencies.

You will be responsible for:

- Monitor regulatory progress, manage deviations, and anticipate risks in obtaining regulatory clearance for medical devices and products.
- Represent Johnson & Johnson (J&J) at local industrial associations and health authorities.
- Plan, organize, and oversee regulatory activities, managing both internal and outsourced resources while prioritizing submissions based on business needs.
- Develop and implement effective regulatory strategies to ensure compliance with local regulations and secure necessary product approvals.
- Set individual objectives for regulatory staff, supervise performance, facilitate development plans, and establish vendor service agreements.
- Maintain and update regulatory databases to ensure accurate submission status reports and dashboards.
- Communicate effectively with customers and respond to franchise business needs in the regulatory submission planning process, serving as a liaison within the regulatory affairs team.
- Foster collaboration with other company departments and align activities with regional and global teams to meet product registration timelines.
- Stay informed about relevant regulatory programs, policies, and trends that may impact company products and proactively influence the regulatory landscape.
- Communicate professionally with team members, J&J personnel, and government agencies.
- Collaborate with local regulators and the RALI Global Strategy & Implementation team to address product submission inquiries.
- Maintain professional competence through industry involvement and continuing education.
- Provide guidance on label content to relevant personnel and recommend necessary changes.
- Conduct training for junior regulatory affairs staff.
- Make informed decisions based on regulatory trends and business requirements in the local market.

**Qualifications**:

- Master's degree or equivalent desired.
- Minimum of 8 years of experience in the medical device, diagnostic, or related industry.
- At least 2 years of direct management experience.
- Experience working in industry working groups or across Johnson & Johnson (J&J) is preferred.
- Multi-country experience is desirable.
- Fluency in English and Spanish.
- Solid knowledge of regulatory requirements with the ability to articulate country requirements to multiple audiences and translate regulations into clear data requirements to support registrations.
- Maintain the highest levels of professionalism, ethics, and compliance at all times.

**Skills**:

- Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives.
- Is aware of and receptive to cultural differences across regions and countries.
- Serves as a technical expert for low complexity projects within job function.
- Strong organizational skills.
- Project management skills.
- Problem solving skills.