Senior Analyst, Regulatory Affairs (Global Planning & Execution) - MedTech Surgery, Inc.

Johnson & Johnson MedTech Surgery is recruiting for a Senior Analyst, Regulatory Affairs Planning & Execution.

The preferred location for this role is within a commutable distance of a MedTech Surgery site in Raritan, NJ or Guaynabo, PR, however candidates in Cincinnati, OH, or Norderstedt, DE will also be considered .

This role will work a Flex/Hybrid schedule with 3 days per week in office .

There is NO remote option.

About Johnson & Johnson

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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/.

The Senior Analyst, Regulatory Affairs Global Planning and Execution is a key partner in the acceleration of global market access.

They are responsible for leading the establishment, implementation, and execution of methods for planning and coordinating MedTech Surgery product submissions globally and support their execution by efficiently planning and facilitating the fulfilment of document and information in compliance with corporate policies and strategies.

They perform capacity planning and bring awareness to resource constraints to meet business submission plans.

Analyze performance metrics and implement action and plans to improve performance.

Interprets new and changing government regulations to ensure compliance with regulatory/government standards.

This role will involve successful collaboration across MedTech Surgery RA Platform and Regional RA Teams.

Key Responsibilities :

• Experienced individual contributor, who operates with minimal direction and in accordance with all applicable federal, state, and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Oversee a high-volume, fast-paced process

• Accelerate market access by supporting regulatory strategies and aligning on regulatory submissions requirements, and execution pathway to ensure timely product approvals.

• Strongly collaborate with MedTech Surgery RA Platform and Regional RA to develop a monthly international submission plan and yearly submission forecast

• Analyze the monthly plan and yearly forecast to evaluate resource capacity, facilitate and lead conversation between RA Teams to align priorities, identify resource constraints and set up plans based on priorities and resource capacity.

• Communicate to upper management conflicting priorities, bring awareness of resource constraints for decision making.

• Identify practices that stand in the way of achieving results and lead process improvements or total process transformation to achieve effic...