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JOB DESCRIPTION:

Johnson & Johnson is hiring for a Manager, Regulatory Affairs – Shockwave Medica l to join our team. The position is FULLY REMOTE and can sit anywhere in the US .
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

POSITION OVERVIEW

The Regulatory Affairs Manager works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements for Shockwave Medical Inc. (SWMI). The Regulatory Affairs Manager combines knowledge of scientific, regulatory and business issues to ensure that products are developed, manufactured and distributed to meet regulatory requirements. With guidance from responsible Regulatory Affairs Management, functions independently as a decision-maker on regulatory issues, assures that submission/registration/renewal deadlines are met, and supports new product development. Effectively communicates, prepares, and negotiates both internally and externally with various regulatory agencies. The Regulatory Affairs Manager properly interprets and applies regulatory requirements and is recognized as a discipline expert and resource in Regulatory Affairs.

REQUIREMENTS

• Minimum 10 years’ experience preferred in a regulated healthcare industry with Bachelor’s degree; or 8 years and a Master’s degree; or a PhD with 4 years experience; or equivalent experience. Degree in science, math, engineering, medical or other technical fields and Class III medical device experience are preferred
• Some medical device software engineering background or experience is preferred.
• Working knowledge of applicable domestic and international regulatory guidelines, policies and regulations
• Experience with pre- and post-market medical device submissions such as 510(k), IDE, PMA, EU Technical Files, Design Dossiers, etc.
• Ability to outline sound regulatory strategy in alignment with regulations and business priorities
• Think analytically with excellent problem-solving skills
• Effectively negotiate internally and externally with regulatory agencies
• Clear and effective verbal and written communication skills with diverse audiences and personnel
• Knowledge of business functions and cross group dependencies/ relationships.
• Leadership of functional groups in the development of relevant data to complete a regulatory submission
• Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues
• Able to effectively lead direct reports while demonstrating flexibility to changing environments.
• Ability to work collaboratively in a fast-paced environment while managing multiple priorities
• Proficient in MS Word, Excel and Power Point
  Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
  Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

Please refer the Job description for details