Regulatory Compliance Engineer

An employer is seeking a regulatory compliance specialist for a six month contract with possible extensions in the Raritan, NJ area. This regulatory compliance specialist will be joining the Internal Audit Program to help the site sustain a state of readiness to applicable regulatory requirements and be responsible for overseeing multiple audits at a time in the medical device space. Compliance functions will include the follow regulations: 21 CFR 820, 21 CFR 4, ISO 13485/EN ISO 13485, ISO 14971/EN ISO 14971, European Medical Device Directive and European Medical Device Regulation. The regulatory compliance engineer will be expected to be on site three days a week and two days a week remote as they will be supporting local internal stakeholders. Prior knowledge of ISO 13485 and FDA regulations are ideal as well as working knowledge of MDSAP. The audits will be managed in an internal tool called ETQ, but any technical tool in the past will suffice as the engineer will utilize, ETQ and all Microsoft platforms. On a day-to-day basis the compliance engineer can expect to lead and manage the reports for the medical device audits they are tied too. Other day to day responsibilities will include external inspection readiness for mock inspections, internal audit management for execution on correction action plans, metrics collection for reporting on audits and external support for implemention new stadard regulations to the site.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to com.
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J&J experience
Degree in science, Engineering or Regulatory Affairs
1-5 years as a regulatory compliance specialist (21 CFR 820, 21 CFR 4, ISO 13485/EN ISO 13485, ISO 14971/EN ISO 14971)
Working knowledge of ISO 13485, FDA, CFR 820
Proficient in Word and ETQ (or any other quality management systems)
Medical Device or Pharmaceutical background