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.