Principal Regulatory Affairs Specialist

Johnson & Johnson is hiring for a Principal Regulatory Affairs Specialist to be located in Minneapolis, MN, Indianapolis, IN, Austin, TX or New Brighton, MN.

At Johnson & Johnson, we believe health is everything. Through our expertise in Innovative Medicine and MedTech, we are positioned to innovate across the full spectrum of healthcare solutions today. Learn more at www.jnj.com.

Shockwave Medical, Inc., acquired by Johnson & Johnson, is a pioneer in Intravascular Lithotripsy (IVL) for treating complex calcified cardiovascular disease.

Description

Position Overview

The Principal Regulatory Affairs Specialist works closely with internal departments to meet regulatory requirements for Shockwave Medical Inc., specifically the Reducer product business. This role combines knowledge of scientific, regulatory, and business issues to ensure compliance.

Essential Job Functions

• Collaboratively interface with various levels on significant matters, coordinating activity across organizational units.
• Develop regulatory policies, processes, and SOPs; train key personnel.
• Develop and update regulatory strategies based on changes.
• Determine submission and approval requirements in assigned geographies; communicate application progress to stakeholders.
• Provide input and guidance on regulatory requirements to product development and operations teams.
• Work with quality and operations to identify and comply with applicable regulations/standards.
• Review and approve documentation for submission filing.
• Compile, prepare, review, and submit regulatory submissions, mainly focused outside the US, as assigned.
• Negotiate with distributors, authorized reps, and regulatory authorities during submission and review processes.
• Evaluate design, clinical, and manufacturing changes for regulatory impact and approve changes in compliance with requirements.
• Maintain annual licenses, registrations, listings for assigned geographies.
• Support product safety evaluation and reporting as required by regulation.
• Provide regulatory input for product recalls and communications.
• Review and approve advertising and promotional materials for compliance.
• Evaluate import/export requirements and identify emerging issues.
• Provide other country-specific regulatory support.
• Write and edit technical documents effectively.
• Plan and conduct meetings, create project plans, and manage projects.
• Exercise good judgment within policy and regulations.
• Perform multiple tasks concurrently with accuracy.
• Guide functional groups in developing data for regulatory submissions.
• Other duties as assigned.

Qualifications

• Minimum of 10 years of related experience with a Bachelor's degree; or 8 years and a Master's degree. Preferred fields: science, math, engineering, medical, or technical fields; Class III medical device experience.
• Ability to work collaboratively in a fast-paced environment while managing multiple priorities.
• Working knowledge of domestic and international regulatory guidelines, policies, and regulations.
• Experience with medical device submissions like 510(k), IDE, PMA, EU Technical Files, and international filings.
• Ability to align regulatory strategy with business priorities.
• Analytical thinking and problem-solving skills.
• Effective negotiation with regulatory agencies.
• Clear communication skills with diverse audiences.
• Knowledge of business functions and cross-group relationships.
• Leadership in developing data for regulatory submissions.
• Ability to identify regulatory data needs and solve issues.
• Team-oriented and flexible to changing requirements.
• Medical device software engineering background preferred.
• Proficiency in MS Word, Excel, and PowerPoint required.

The anticipated base pay range for this position is $103,000 to $165,600. This position is eligible for an annual performance bonus. Employees may participate in a range of Company sponsored benefit programs including medical, dental, vision, and retirement plans.

Time Off Benefits

• Vacation – up to 120 hours per calendar year
• Sick time – up to 40 hours per calendar year; 56 hours for those in Washington State
• Holiday pay, including Floating Holidays – up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

For additional information on Company benefits, please visit www.careers.jnj.com/employee-benefits.