The Regulatory Affairs Specialist provides regulatory guidance in areas including regulatory strategy for product submissions and regulatory compliance activities. Develops and maintains domestic and international submissions. Reviews international and domestic labeling, marketing communications and product design documentation ensuring compliance with regulatory requirements.
Regulatory Affairs Specialist responsibilities:
* Interacts with regulatory agencies with facilities inspections, licensures and permits.
* Supports regulatory compliance to ISO 13485:2016, 21CFR820, MHLW, ANVISA, 93/42/EEC, CMDR, MDR, TG(MD)R Sch3.
* Supports the implementation of the European Medical Device Regulation.
* Participates in and approves product risk assessments.
* Prepares product registration files in international markets with local representatives and obtains local approvals and shipping authorization.
* Identifies risks within regulatory strategies and clearly communicates risks to project teams and regulatory affairs management.
* Reviews, interprets and communicates FDA/international regulations and guidance documents to ensure complete scientifically sound product submissions.
* Conducts internal audits/surveillance to ensure adherence to company procedures/policy in the areas of quality, safety and training.
* Interprets regulatory rules or rule changes and ensures they are communicated through organizational policies and procedures.
* Compiles regulatory filings for EU MDR and rolls them out to the company.
* Provides guidance to assure all regulatory submissions are planned, communicated and executed per regulatory and business requirements.
* Serves as a subject matter expert on various regulations and coordinates regulatory issue resolution by using internal resources, regulatory agencies, and outside consultants as need.
* Maintains proficiency in broad, regional regulatory requirements.
* Supports Research and Development department testing.
Regulatory Affairs Specialist background requirements:
* Degree in Engineering, Quality or a related field.
* Bachelor's degree and two years of technical experience or Associate's degree and five years of technical experience.
* Experience with inspection, testing, and troubleshooting.
* Experience in multiple types of international regulatory submissions (China, Korea, Saudi Arabia, Brazil, Australia, Columbia, Singapore, India, Taiwan, Malaysia, and Vietnam).
* Working knowledge of FDA, ISO, EU and other applicable regional regulations for handling complaints, reporting incidents, and implementing corrective and preventative actions.
* Knowledge of cGMP regulations ISO 13485, 21CFR Part 820, CMDR SOR/98-282, 93/42/EEC, RDC , MHLW MO 169 and TG(MD)R Sch3 preferred.
Sthree US is acting as an Employment Agency in relation to this vacancy.