Job Title: Principal RA - Post Market Surveillance
We are seeking a highly skilled Regulatory Affairs Principal to lead post-market activities for Administration and Safety System medical devices.
Key Responsibilities:
* Accountable for Global Post Market Surveillance and Vigilance Activities for Administration and Safety System medical devices in West's portfolio.
* Support establishment and maintenance of procedures, work instructions, and templates associated with Post Market activities.
* Execute post-market surveillance plans in the commercial lifecycle including periodic review and reporting requirements.
Requirements:
* Bachelor's or master's degree in nursing, engineering or related discipline.
* 10-12 years of experience in medical device, pharmaceutical or regulatory industry.
* Advanced knowledge of US Class II and EU Class IIa device experience.
Preferred Qualifications:
* International regulatory competency.
* Advanced degree.
* R.A.C certification(s).
Travel Requirements:
Must be able to travel up to 5 – 10 % of the time (audits, meeting, training, industry events).
Salary Range:
$120,000 - $160,000 per year.