Regulatory Affairs Specialist
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Job Summary
Responsibilities:
- Preparing documentation for international regulatory registrations.
- Preparing technical documentation to compliant to MDD and EU MDR.
- Defining worldwide regulatory requirements are necessary for regulatory approval of products.
- Participating in cross functional teams as regulatory lead.
- Maintaining regulatory documentation to ensure availability for external audits and preparation of submission packages.
- Authoring submissions researching requirements setting priorities and maintaining project schedules.
- Providing guidance and oversight to team members related to regulatory compliance.
- Reviewing marketing literature for compliance with applicable regulations.
- Executing on additional responsibilities as defined by management.
- Act as a Subject Matter Expert (SME) to support internal and external audits.
- Bachelors degree in science Engineering or other relevant disciplines.
- Minimum 5-8 years experience in Regulatory Affairs in the medical device industry.
- FDA EU Health Canada and international registrations experience.
- Working knowledge with quality system regulations and guidelines.
- Ability to develop clear concise and timely oral and written reports.
- Great communication skills with all levels of personnel.
- High level of organization and planning skills.
- Working knowledge of medical devices procedures and terminology.
- Drug-combination experience a plus.
Key Skills
- Athletics
- Corporate Banking
- Dreamweaver
- Facilities
- IT Support
