[Hiring] Regulatory Affairs Specialist II @Johnson & Johnson Innovative Medicine

Role Description

Johnson & Johnson MedTech, Neurovascular, is recruiting a Regulatory Affairs Specialist II to join our team. This position is remote anywhere within the continental United States.

The Regulatory Affairs Specialist II position offers the opportunity to have a significant impact on patient access to innovative neurovascular products around the world! The role will primarily support regulatory activities to obtain and maintain medical device approvals/clearances in the US and European markets. This role will support preparation, submission, tracking, indexing, and archiving of official documents and files such as:

• Technical Documents
• Amendments/Supplements
• Annual Reports
• General Correspondence
• Promotional Materials
• Other EU or US regulatory submissions

The individual will work closely with other Global Regulatory Affairs partners and with functional partners in:

• Research and Development (R&D)
• Medical Affairs
• Quality
• Supply Chain
• Marketing
• Other functions

Qualifications

• Required: BS with 2+ years of experience, or PhD, MS degree
• Strong written and verbal communication skills, especially for conveying technical, scientific, and medical information in multiple technology formats and to different audiences
• Some knowledge of US and European regulatory processes
• Experienced in working as a member of a team
• Ability to communicate in a constructive manner to encourage new, diverse ideas so decisions can be made in alignment with business objectives and the J&J Credo
• Capability to work in an environment of innovative thinking, informed risk taking, intellectual curiosity, and continual learning of regulatory developments
• Language requirement: Proficiency in speaking, reading, and writing in English

Requirements

• Training in US and/or EU medical device regulations
• Practical experience in a medical device regulatory environment
• Practical experience working within a medical device quality system
• Practical experience preparing submissions for Class II and III medical devices in the US and EU

Benefits

• Vacation – 120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
• Holiday pay, including Floating Holidays – 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year