Regulatory Affairs Associate

Description:

This position will be responsible for assisting the Regulatory Affairs initiatives and registrations/listings for all Sunset products for the US and EU markets. The position will mostly support Class I Medical Device Products Compile and maintain regulatory documentation databases or systems. Coordinate efforts associated with the preparation of regulatory documents or submissions. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. Coordinate, prepare, or review regulatory submissions for domestic or international projects. Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures. Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents. Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards. Participate in internal or external audits. Prepare or direct the preparation of additional information or responses as requested by regulatory agencies. Prepare or maintain technical files as necessary to obtain and sustain product approval.

Skills:

Regulatory Affairs, Medical Device, Regualtory Documents, FDA, EU MDR, Global Registration, Regulatory Submissions, cGMP, ISO 13485:2016, MDSAP

Top Skills Details:

Regulatory Affairs,Medical Device,Regualtory Documents

Additional Skills & Qualifications:

BS Degree Preferred - but not required 1-3 years of Regulatory Affairs experience in Medical Device EU MDR experience would be preferred.

Experience Level:

Entry Level