Principal Clinical Evaluation Specialist - Shockwave Medical

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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Medical Affairs Group Job Sub Function: Medical Writing Job Category: Professional All Job Posting Locations: Santa Clara, California, United States of America Job Description: Johnson & Johnson is hiring for a Principal Clinical Evaluation Specialist – Shockwave Medical to join our team! This role is fully remote in the United States.   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/ .   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.

Overview The Principal Clinical Evaluation Specialist requires experience in the writing of medical device clinical regulatory documents. The position will mainly focus on development of Clinical Evaluation Reports (CERs) and associated documents including Clinical Evaluation Plans (CEPs), Literature Search Protocols and Reports (LSPs/LSRs) and Post Market Clinical Follow-up (PMCF) Plans and Reports. The main purpose of this job is to author and develop clinical evaluation reports (CERs) per MEDDEV 2.7.1 Rev 4 and MDR regulations to meet essential requirements in support of submission for CE Mark application to obtain Declaration of Conformity and EU market clearance, recertification, and proposed indication/labeling changes, as well as CER updates to maintain EU product conformance. This job may be expanded to support other clinical evidence documents, including the support of the clinical sections of a PMA/PMAs (US Class III), IDE (US Class II/III), 510K (US Class III), other international medical device applications or other technical writing needs as applicable.  Essential Job Functions Authors clinical documentation- mainly the Clinical Evaluation Reports (CER) and supporting ancillary documents (CEPs, LSP, LSR, PMCF) including the clinical section of regulatory authority requests for the entire portfolio. Acquires knowledge of therapeutic areas, competitor devices, current clinical/market developments, literature review processes and the ability to stay current with current literature. Develops comprehensive, systematic literature search protocols, supports in-depth literature searches for CERs and other clinical evidence reports and