Senior Regulatory Affairs Specialist - Johnson & Johnson MedTech | Cardiovascular

Johnson & Johnson; Wokingham; Hybrid; GBP 50,000 - 75,000; Full time

Job summary

A leading company in healthcare innovation is seeking a Senior Regulatory Affairs Specialist for Shockwave Medical. This hybrid role focuses on meeting regulatory requirements for medical devices across various regions. The successful candidate will guide teams in developing regulatory strategies, manage submissions, and ensure compliance with evolving regulations.

Qualifications

• Minimum 5 years regulatory affairs experience in medical devices.
• Ability to manage multiple priorities in a fast-paced environment.
• Knowledge of medical device submission processes.

Responsibilities

• Coordinate on regulatory matters and ensure compliance.
• Prepare and submit regulatory submissions on time.
• Engage with regulatory authorities during development.

Skills

Regulatory guidelines knowledge

Communication skills

Organizational skills

Regulatory strategy skills

Education

Relevant degree in regulatory affairs

Master's degree

PhD

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 Details

Job Function: Regulatory Affairs Group

Job Sub Function: Regulatory Affairs

Job Category: Professional

Location: Wokingham, Berkshire, United Kingdom

Job Description

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

About Shockwave

We are developing next-generation, less invasive, personalized treatments at the intersection of biology and technology. Join us in pioneering Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our portfolio aims to establish a new standard of care through proprietary sonic pressure wave technology for treating calcified plaque.

Role Purpose

The Senior Regulatory Affairs Specialist works closely with internal teams 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 deadlines are met, and support new product development.

Key Responsibilities

1. Coordinate with various organizational levels on regulatory matters.
2. Outline submission and approval requirements for assigned regions.
3. Develop regulatory strategies aligned with business priorities and adapt to regulatory changes.
4. Provide regulatory guidance to product development and operations teams.
5. Assist with interpretation of applicable regulations and standards (ISO, IEC, ROHS, 21 CFR, etc.).
6. Prepare and submit high-quality regulatory submissions on time, supporting international submissions as needed.
7. Engage with regulatory authorities during development and review processes.
8. Maintain current regulatory policies and procedures.
9. Communicate effectively with internal teams and external agencies.
10. Evaluate design, clinical, and manufacturing changes for regulatory impact.
11. Manage licenses, registrations, and product safety reporting.
12. Support product recalls and audits.
13. Maintain regulatory documentation and track emerging issues.
14. Exercise ethical judgment within policies and regulations.
15. Manage multiple tasks concurrently with accuracy.
16. Guide teams in developing data for regulatory submissions.

Qualifications

• Minimum 5 years of regulatory affairs experience in medical devices with a relevant degree; or 3 years with a Master’s; or a PhD without experience; or equivalent experience. Class III device experience preferred.
• Ability to work 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 (EU Technical Files, Design Dossiers, MDR, Swiss MedDO).
• Strong regulatory strategy skills aligned with business needs.
• Excellent communication skills for diverse audiences.
• Organized with the ability to manage multiple projects.
• Some background in medical device software engineering is preferred.
• Proficiency in MS Word, MS Teams, Excel, Adobe, PowerPoint.