Senior RA Specialist - Med Device - Burlington, MA
An opportunity to own all of the post market RA functions.
This company inspires their employees to strive beyond industry standards.
About Our Client
Our client is a combination medical device company that has been a leader in IVD products for over 25 years.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
- Lead, conduct and support complaint investigations for the client through close collaboration with Research and Development, Manufacturing, Sales and Marketing and other departments; Accountable for accuracy and quality of investigations; Assure that medical device incidents/complaints are documented, reviewed, investigated, trended, and reported in accordance with current procedures.
- Lead weekly complaint review meetings to share and discuss complaint issues and trends with member of the leadership team.
- Lead and perform complex investigations, coordinate and support Failure Investigations and lead projects related to complaint handling to include communication with Physician Users, patients, or medical facility personnel.
- Improve product performance of fielded devices via Customer Defect Tracking and Resolution to improve overall customer experience.
- Investigate and perform Risk Assessments of complaints through the Corrective and Preventative Action process, determine root cause of non-conformance, and recommend changes or corrections.
- Lead the daily activities of the Complaint Handling process and ensure adequate and timely conduct and documentation of investigations.
- Lead operational processes to include scheduling of priorities, monitoring status, performance reviews and overall support.
The Successful Applicant
- MS or BS in regulatory affairs or a scientific discipline, or equivalent experience; combination of training and experience will be taken under consideration
- 5 years' minimum experience as a Regulatory Associate or Regulatory Specialist with direct submission experience
- Working knowledge and understanding of ICH, GCP and relevant regulatory agency requirements domestically and internationally, including pending and recently approved regulations
- Three years (minimum) of direct experience in submissions to competent authorities, with emphasis on the FDA,and experience in evaluating scientific data and reports
- Knowledge of Common Technical Document (CTD) submission format
- Experience with direct quality and version control of documents
- Organized, detail oriented, and excellent written and oral communication skills
- Work independently, functioning within a multidisciplinary team environment
- Excellent skills in prioritization, problem solving, organization, decision-making, time management
What's on Offer
- Competitive compensation
- Premiums for health, dental, disability, and term life insurance
- 401k savings plan with company match