Regulatory Affairs Specialist - Katalyst Healthcares & Life Sciences
South Plainfield, NJ 07080
About the Job
Responsibilities and Requirements:
- Support daily Regulatory Affairs function eg; compliance to 21 CFR 820,807,803 ISO 13485 requirements, Company policies, operating procedures, processes, promotional task assignments into windchill and assigned training.
- Responsible for PSUR, CER, HHE, Impact assessments (Post market surveillance activities).
- Provide Regulatory support in Manufacturing Plant Transition Project, Quarterly Management Reviews.
- Provides regulatory expertise in any significant or non-significant changes.
- Support in maintaining and developing global regulatory strategies.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Assist in PMS activities, and audit preps.
- Review and provide regulatory feedback on risk management plans/reports, Health Hazard Analysis, Adverse events by working cross functionally with Quality and Design team.
- Initiate, Review and Approve, NCMRs, CAPAs, Reworks etc.
- Reviews product and manufacturing changes for compliance with applicable regulations.
- Reviews protocols and reports to support regulatory compliance and submissions.
- Responsible for communicating with agencies for any Notification, Field actions, Adverse Events, Significant/Non-Significant Changes etc.
- Maintain Design Dossiers and Letter to Files.
- May provide assistance in processing pending invoices to any customers or agencies.
- Able to develop and maintain Risk Management.
- Bachelor's degree (BS, BA).
- 4 years' Regulatory experience.
- Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
- Ability to work effectively within a team in a fast-paced changing environment.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Source : Katalyst Healthcares & Life Sciences
