Sr. Regulatory Specialist II

Organization: 
Roche
Job Location: 
Branchburg, NJ
Job Description: 

The position:

  • •Participate in Product Problem Meetings relating to complaints and product problems to determine the need for CAPA and identify if issues may need to be reviewed for Safety Board action.
  • •Review Complaint Summaries for the following applications-related complaints: Potentially Critical Complaints, complaints requiring CAPA and complaints that indicate product is non-conforming.
  • •Prepare and document Safety Board statements for Potentially Critical Complaints during the complaint process workflow.
  • •Complete decision trees for Potentially Critical Complaints, in conjunction with applicable functional areas, for Adverse Event Reporting assessments.
  • •Prepare and submit Adverse Event Reports (including Medical Device Reports and Biological Product Deviation Reports, as needed) for Potentially Critical Complaints and product non-conformities that require regulatory reporting.
  • •Prepare Safety Board Situational Analysis and subsequent Safety Board Meeting Minutes, including obtaining medical/regulatory input and distribution information.
  • •Prepare Field Correction and Product Removal documentation as per regulatory requirements, including liaison to obtain Health Hazard Evaluation information from Medical Affairs.
  • •Respond to Affiliate and/or Regulatory Agency requests for information pertaining to Adverse Event Reports, Field Actions, Product Removals or any other product compliance/safety issue.
  • •Track and monitor Safety Board activities and documentation.
  • •Prepares Safety Board and Vigilance metrics, trending, and other customized reports.
  • •Participate in product Post Launch Review.
Requirements: 

Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies, and where a job title is not considered the final definition of who you are, but the starting point.

Education:

  • •Required: Bachelor’s degree in science, med tech, nursing or related field, or equivalent combination of education and work experience.
  • •Preferred: Master’s degree in science, nursing, or regulatory affairs.



Certifications:

  • •Preferred: Regulatory Affairs Professional.



Job-related Experience:

  • •Required: 5 years in a CBER, CDER or CDRH regulated facility, and experience in a clinical environment.
Contact Information: 

The next step is yours. To apply online today and to learn about other exciting positions, please go to: careers.roche.com and enter Job ID #2597416625 in the “Keyword” box underneath the Global Job Search field. Roche is an Equal Opportunity Employer.

About Our Organization: 

Who we are
At Roche, 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity, and on seeing each other’s differences as an advantage. To innovate healthcare, Roche has ambitious plans to keep learning and growing – and is seeking people who have the same goals for themselves.