Senior Regulatory Affairs Specialst

Job Responsibilities

• Process SME to ensure appropriate coordination and advise on consistent interpretation of required data attributes
• Keeps abreast of regulatory procedures and changes.
• Provide requested regulatory data and documents to support tenders
• Lead in development/maintenance of regulatory files, data, records, and reporting systems of systematic retrieval of information.
• Prepare, review, file, and support premarket documents for global registrations for assigned projects.
• Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations for assigned projects.
• Preparation of document packages for international regulatory submissions from all areas of company, internal audits and inspections.
• Compiles all materials required in submissions, license renewal and annual registrations
• Recommends changes for labelling, manufacturing, marketing and clinical protocol for regulatory compliance
• Monitors and improves tracking/control systems
• May direct interaction with regulatory agencies on defined matters.
• Develop Regulatory Strategies for new or modified products for assigned projects.
• Monitor and provide information pertaining to impact of changes in the regulatory environment.
• Communicate with regulatory agencies and/or notify bodies on administrative and routine matters.
• Document, consolidate, and maintain oral and written communication with health authorities
• Prepare internal documents for modifications to devices, when appropriate.
• Author and/or review regulatory procedures and update as necessary.
• Review change control documents and ascertain regulatory impact for external and internal documents through formal regulatory assessments.

Minimum Qualifications

• Bachelor s degree in Medical, Mechanical, Electric Life Science or other healthcare related majors
• 7+ years experiences for RA role in medical device and or pharmaceutical industry. A mix is preferred in case of pharam.
• Works independently with general supervision on larger, moderately complex projects / assignments.
• Contributes to the completion of project milestones.
• Adjusts or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
• Ability to quickly establish credibility with all levels of customer base
• Communicates primarily and frequently with internal contacts. Contacts others to share information, status, needs and issues to inform, gain input, and support decision making

Nice to Haves

• US and global regulatory affairs knowledge and experience.
• Experience working with cross-functional teams.
• Effective verbal and written communication skills both internally and externally.
• Experience with solving problems and concerns.
• Experience with project management and adherence to time schedules.
• Work well under pressure in a dynamic environment.
• Highly organized, detail-oriented, and efficient.
• Team player who seeks to help and learn from colleagues seeing the department success as their own
• Ability to manage projects to completion within and outside of the direct department and company.
• Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism
• Proactively seeks to develop and become well-versed within the regulatory landscape.
• RAPS Regulatory Affairs Certification (RAC).