5 часов назад
Senior Regulatory Affairs Program Lead (MedTech)
109 000 - 174 800$
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Regulatory Affairs Program Lead (Medical Devices): Developing and executing regulatory strategies for OTTAVA robotic instruments and accessories, preparing FDA and global health authority submissions with an accent on new product development, device testing, risk management, and market access. Focus on authoring complex submissions, evaluating regulatory changes, supporting engineering and clinical teams, and resolving issues that affect registration status.
Location: Cincinnati, Ohio; Santa Clara, California; Raritan, New Jersey, or Remote (US). Preference is given to candidates within commuting distance of Cincinnati, Santa Clara, or Raritan; remote work may be considered case by case. The role requires up to 25% travel.
Salary: $109,000–$174,800 base pay; Bay Area range: $125,000–$201,250.
Company
Johnson & Johnson MedTech develops surgical technologies and healthcare solutions, including robotics, instruments, and accessories.
What you will do
- Develop and execute regulatory strategies for new product clearances and approvals for the OTTAVA robotics portfolio.
- Prepare, author, and file FDA submissions, including Q-submissions, IDEs, De Novo submissions, and 510(k)s.
- Prepare global health authority submission documents to support international market access.
- Provide regulatory expertise to engineering, clinical, and new product development teams, including reviews of specifications, testing, risk management, and design-control documentation.
- Evaluate device changes against applicable geographic requirements and prepare regulatory submissions, including Letters to File.
- Support health authority interactions, regulatory process development, labeling and promotional content compliance, and resolution of registration-impacting issues.
Requirements
- Bachelor’s degree in science, engineering, or a related field; an advanced degree is highly desired.
- At least 6 years of related regulatory affairs experience in medical devices, or 4 years with an advanced degree.
- Experience with medical device regulatory submissions and developing and implementing regulatory strategies.
- Knowledge of global product registration requirements and experience with health authority meetings or interactions.
- Experience with medical device software guidance, IEC 60601, sterilization, biocompatibility, and reprocessing requirements and submission documentation.
- Advanced analytical, problem-solving, communication, organization, and prioritization skills, with the ability to lead multiple projects.
Culture & Benefits
- Collaborative, cross-functional work with engineering, clinical, and global regulatory colleagues.
- Inclusive work environment focused on respect, diversity, and individual contributions.
- Participation in retirement, pension, and 401(k) savings plans, subject to plan terms.
- Vacation, sick time, holiday pay, parental leave, caregiver leave, bereavement leave, volunteer leave, and other personal and family time benefits.
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