Regulatory Affairs Specialist II - JJMT Neurovascular
WFA Digital Insight
As the demand for skilled regulatory professionals continues to rise, with a 25% increase in job postings over the past year, Johnson & Johnson's Neurovascular division is seeking a talented Regulatory Affairs Specialist II to join their team. With the ability to work remotely, this role offers a unique opportunity to utilize digital skills in a dynamic and innovative environment. Candidates with experience in medical device regulation and a strong understanding of global market requirements will be well-suited for this position. Before applying, it's essential to understand the company's commitment to diversity and inclusion, as well as the role's potential impact on patient access to life-changing neurovascular products.
Job Description
About the Role
The Regulatory Affairs Specialist II position is a critical component of Johnson & Johnson's Neurovascular division, responsible for supporting regulatory activities to obtain and maintain medical device approvals and clearances in the US and European markets. This role will provide the opportunity to work closely with cross-functional teams, including Research and Development, Medical Affairs, Quality, and Marketing, to ensure compliance with all applicable laws and regulations. As a key member of the Regulatory Affairs team, the successful candidate will be expected to provide expertise and guidance on regulatory matters, leveraging their knowledge of medical device regulation to drive business results.The day-to-day responsibilities of this role will include supporting the preparation, compilation, and submission of regulatory documents, as well as responding to regulatory authority queries and deficiency letters. The ideal candidate will have a strong understanding of global market requirements, including those related to medical device approvals and clearances in the US and EU. With a focus on innovation and patient access, this role offers the opportunity to make a meaningful impact on the development and commercialization of neurovascular products.
What You Will Do
- Support the preparation, compilation, and submission of regulatory documents, including 510(k), IDE, PMA, and HDE submissions
- Respond to regulatory authority queries and deficiency letters, providing clear and concise responses to ensure timely resolution
- Collaborate with cross-functional teams, including R&D, Medical Affairs, Quality, and Marketing, to ensure compliance with all applicable laws and regulations
- Develop and maintain regulatory documents and records, including Technical Documentation, Design Dossiers, and Letters to File
- Review proposed labeling, packaging, and promotional materials to ensure conformance to applicable global market regulations
- Support the creation and maintenance of regulatory documents and records related to FDA submissions, Technical Documentation, and Design Dossiers
- Attend regular meetings with project teams to discuss product development and product changes
- Complete assigned duties in compliance with all International, Federal, State, local, and Company regulations, requirements, policies, and procedures
- Collaborate with other Global Regulatory Affairs partners to ensure alignment and consistency across the organization
What We Are Looking For
- Bachelor's degree in a relevant field, such as life sciences, engineering, or a related field
- Minimum 2-3 years of experience in regulatory affairs, with a focus on medical device regulation
- Strong understanding of global market requirements, including those related to medical device approvals and clearances in the US and EU
- Excellent communication and interpersonal skills, with the ability to work effectively in a cross-functional team environment
- Proficiency in Microsoft Office, including Word, Excel, and PowerPoint
- Experience with electronic document management systems and regulatory submission software
- Strong analytical and problem-solving skills, with the ability to interpret and apply regulatory requirements
- Certified Regulatory Professional (CRP) or Regulatory Affairs Certification (RAC) preferred
Nice to Have
- Experience with neurovascular products or medical devices
- Knowledge of EU MDR and US FDA regulations
- Familiarity with Quality Management Systems, such as ISO 13485
- Experience with project management tools and software
Benefits and Perks
- Competitive salary and benefits package
- Opportunity to work remotely, with flexible working hours
- Comprehensive health and wellness programs, including medical, dental, and vision coverage
- 401(k) matching and retirement savings plan
- Paid time off and holidays, with a generous vacation policy
- Access to professional development and training programs, including regulatory affairs certification
How to Stand Out
- Ensure your resume and cover letter are tailored to the specific requirements of the Regulatory Affairs Specialist II role, highlighting your experience in medical device regulation and global market requirements.
- Develop a strong understanding of Johnson & Johnson's company culture and values, and be prepared to discuss how your skills and experience align with the organization's mission.
- Prepare examples of your experience with regulatory submissions, including 510(k) and PMA submissions, and be prepared to discuss your approach to regulatory strategy and compliance.
- Familiarize yourself with the company's products and services, including neurovascular products, and be prepared to discuss your knowledge of the industry and market trends.
- Consider obtaining regulatory affairs certification, such as CRP or RAC, to demonstrate your expertise and commitment to the field.
- Research the company's diversity and inclusion initiatives, and be prepared to discuss your experience working in a diverse and inclusive environment.
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