Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead regulatory strategies and ensure compliance for innovative medical devices.
- Company: Join Johnson & Johnson, a leader in healthcare innovation dedicated to improving lives.
- Benefits: Enjoy a hybrid work model, competitive salary, and opportunities for professional growth.
- Why this job: Be part of groundbreaking projects that redefine treatment standards and impact global health.
- Qualifications: 5+ years in regulatory affairs; experience with medical devices is essential.
- Other info: Opportunity to collaborate with diverse teams and travel as needed.
The predicted salary is between 43200 - 72000 £ per year.
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.
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.
Senior Regulatory Affairs Specialist - Shockwave employer: Johnson & Johnson MedTech
Contact Detail:
Johnson & Johnson MedTech Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Specialist - Shockwave
✨Tip Number 1
Familiarise yourself with the specific regulatory requirements for medical devices in the EU, UK, and Switzerland. Understanding these regulations will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with medical devices. Engaging with industry experts can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Stay updated on the latest trends and changes in regulatory policies related to medical devices. This knowledge can be a great conversation starter during interviews and shows that you are proactive in your field.
✨Tip Number 4
Prepare to discuss specific examples from your past experience where you successfully navigated regulatory challenges. Highlighting your problem-solving skills and ability to work under pressure will make you stand out as a candidate.
We think you need these skills to ace Senior Regulatory Affairs Specialist - Shockwave
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly read the job description for the Senior Regulatory Affairs Specialist position at Johnson & Johnson. Understand the key responsibilities and required qualifications to tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasise your regulatory affairs experience in the medical device industry. Be specific about your achievements and how they relate to the requirements listed in the job description, such as experience with EU Technical Files and Design Dossiers.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also demonstrates your passion for healthcare innovation. Mention how your skills align with the mission of Johnson & Johnson and the specific goals of Shockwave Medical.
Proofread Your Application: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. A polished application reflects attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at Johnson & Johnson MedTech
✨Understand Regulatory Frameworks
Familiarise yourself with the specific regulatory frameworks relevant to the medical device industry, particularly in the EU and UK. Be prepared to discuss how these regulations impact product development and compliance.
✨Showcase Your Experience
Highlight your previous experience in regulatory affairs, especially any work related to medical devices. Be ready to provide examples of successful submissions or strategies you've developed that align with business priorities.
✨Demonstrate Communication Skills
Since the role involves interfacing with various teams and regulatory authorities, practice articulating complex regulatory concepts clearly and concisely. Prepare to discuss how you’ve effectively communicated regulatory requirements to diverse audiences.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills and ethical judgement in regulatory situations. Think about past challenges you've faced and how you navigated them while ensuring compliance.
