Regulatory Affairs Specialist
Responsibilities may include the following and other duties may be assigned:
- 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.
- Review pre-clinical, and clinical protocols and associated reports to be used in submissions for assigned projects.
- Develop Regulatory Strategies for new or modified products for assigned projects.
- Monitor and provide information pertaining to impact of changes in the regulatory environment.
- Document, consolidate, and maintain oral and written communication with health authorities.
- Prepare internal documents for modifications to devices, when appropriate.
- Compiles all materials required in submissions, license renewal and annual registrations.
- Participate in health agency inspections & notified body audits as necessary.
- 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.
- Assist in development/maintenance of regulatory files, records, and reporting systems of systematic retrieval of information.
- Review promotional material, advertising, and labeling to ensure regulatory compliance on assigned projects.
- Ensure compliance to regulations specific to clearance and approvals of OU developed product s raw material and/or prototype.
Required Knowledge and Experience:
- Bachelor s degree in medical, Mechanical, Electric Life Science or other healthcare related majors.
- 4-7 year s experience for RA role in medical device and or pharmaceutical industry. A mix is preferred in case of pharma.
- Good understanding for regulations and policies issued by India, US FDA and EU, and ability to interpret international regulatory requirements.
- Excellent written, organizational, and communication skills is required, and have a flexible and team-oriented attitude.
- Strong attention to details and ability to handle multiple tasks, good at planning and can work under pressure, Good at English including reading, writing, and speaking.
- Good Learning attitude.
Nice to Have - 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 we'll 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 we'll-versed within the regulatory landscape.
- RAPS Regulatory Affairs Certification (RAC).
