Regulatory Affairs Specialist (RA specialist)

The Regulatory Affairs Specialist will support all regulatory affairs activities worldwide. Will generate and assure compliance of regulatory submissions documents for new products or changes to existing regulatory submissions and/or approvals, and will generate reportable events to relevant authorities.
REPORTS TO: Director of clinical and regulatory affairs
ESSENTIAL DUTIES AND RESPONSIBILITIES:
· Support preparation of worldwide regulatory strategies, submissions, registration and documentation
· Perform coordination and preparation of documents packages for regulatory submissions from all areas of the company (collaborate with Marketing, Clinical, R&D, Engineering and other departments as needed)
· Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
· Provide regulatory guidance for product’s requirements and changes.
· Prepare or maintain technical files as necessary to obtain and sustain product approval.
· Maintain Medical Device operations licenses for the relevant countries.
· Manage internal and external audits and inspections and provide post-audit follow-up information.
· Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific accuracy and clarity of presentation.
· Review product promotional materials, labelling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
· Evaluate current and new products for compliance with applicable regulations.
· Compile and maintain regulatory documentation databases.
· Review product complaints and reports to relevant regulatory authorities, as applicable.
· Maintain current knowledge base, identify, and interpret regulatory rules/guidance/ standards and ensure that they are communicated through corporate policies, procedures, work instructions.
· Review adverse device effects and file all related reports in accordance with regulatory agency guidelines.
· Write comprehensible, user-friendly, clear product information leaflets and labels.
· Initiate & maintain RA related SOP’s. Recommend changes to company procedures in response to changes in regulations or standards.
· Oversee risk management procedures.
REQUIREMENTS
· 5+ years experience in an RA position, supporting worldwide submissions (CE, FDA, PMDA, Australia, Canada, Israel, etc).
· Academic degree
· Extensive experience & knowledge & in medical device regulations.
· Excellent analytical abilities.
· Full working proficiency in English.
· Excellent communication skills, both verbal and written.