Senior Regulatory Affairs Specialist - Shockwave

Johnson & Johnson MedTech; Wokingham; Hybrid; GBP 50,000 - 80,000; Full time

Job summary

Join a leading company in healthcare innovation as a Senior Regulatory Affairs Specialist, where you will be responsible for navigating the regulatory landscape for exciting medical technologies. This hybrid role in Wokingham involves developing regulatory strategies, guiding product development, and ensuring compliance across multiple regions. Bring your expertise in regulatory affairs and make an impact on healthcare solutions.

Qualifications

• Minimum 5 years in regulatory affairs for medical devices.
• Ability to manage multiple priorities.
• Strong knowledge of EU Technical Files and Design Dossiers.

Responsibilities

• Interface with various departments to coordinate regulatory activities.
• Develop regulatory strategies and ensure compliance.
• Compile, prepare, and submit regulatory submissions on time.

Skills

Regulatory guidelines knowledge

Communication skills

Organizational skills

Ability to work collaboratively

Flexibility

Education

Bachelor’s degree in relevant field

Master’s or PhD in relevant field

Tools

MS Word

MS Teams

Excel

Adobe

PowerPoint

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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.

Job Function

Regulatory Affairs Group

Job Sub Function

Regulatory Affairs

Job Category

Professional

All Job Posting Locations:

Wokingham, Berkshire, United Kingdom

Job Description

Johnson & Johnson MedTech is recruiting a Senior Regulatory Affairs Specialist for Shockwave Medical, a hybrid role based in Wokingham.

About Shockwave

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Our Shockwave Medical portfolio aims to establish a new standard of care for treating calcified cardiovascular disease with sonic pressure waves for plaque treatment.

Role Purpose

The Sr. Regulatory Affairs Specialist works closely with internal departments to meet regulatory requirements for Shockwave Medical, Inc. (SWMI), focusing on the EU, UK, Switzerland, and other geographies. They act as a decision-maker on regulatory issues, ensure registration/renewal deadlines are met, and support new product development.

What You Will Be Doing

• Interface with various levels on significant matters, coordinating across organizational units.
• Outline submission and approval requirements in assigned regions.
• Develop regulatory strategies aligned with business priorities, updating as needed.
• Provide regulatory input and guidance to product development and operations teams.
• Identify applicable regulations and standards, assisting with interpretation and compliance.
• Compile, prepare, review, and submit regulatory submissions on time in the US and other regions.
• Interact with regulatory authorities during development and review processes.
• Communicate application progress internally.
• Maintain current regulatory policies, processes, and procedures.
• Negotiate with regulatory agencies and evaluate design, clinical, and manufacturing changes for compliance.
• Maintain licenses and registrations, support product safety evaluations, and assist with recalls and audits.
• Maintain regulatory files and track databases, identify emerging issues, and exercise ethical judgment.
• Manage multiple tasks accurately and guide teams in data development for submissions.

What You Will Bring

• Minimum 5 years of regulatory affairs experience in the medical device industry with a Bachelor's degree; or 3 years with a Master’s; or a PhD without experience; or equivalent.
• Ability to work collaboratively in a fast-paced environment, managing multiple priorities.
• Willingness to travel as needed.
• Knowledge of regulatory guidelines, policies, and regulations.
• Experience with medical device submissions, including EU Technical Files and Design Dossiers.
• Ability to develop regulatory strategies aligned with regulations and business needs.
• Excellent communication skills for diverse audiences.
• Organizational skills to manage multiple projects effectively.
• Flexibility to operate independently or as part of a team.
• Preferred background in medical device software engineering.
• Proficiency in MS Word, MS Teams, Excel, Adobe, and PowerPoint.