What are the responsibilities and job description for the Regulatory Affairs Specialist I position at Integrated Resources, Inc ( IRI )?
Essential Duties And Responsibilities
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
Education
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
- Responsible for the preparation and compiling of document packages for regulatory submissions, audits and inspections. Participates in technical review of data or reports that will be incorporated. Manage and maintain regulatory databases and technical files.
- Participate in internal and external audits and investigations.
- Reviews materials such as labeling, marketing materials or user manuals to ensure compliance with regulatory agency requirements and laws.
- Manage labeling and unique device identification requirements. Recommends changes for labeling, manufacturing, marketing and clinical protocols for regulatory compliance.
- Provides high-level regulatory support on projects and cross functional teams. Provides technical guidance on design reviews and regulatory strategies for product approval.
- Contribute to developing or improving processes, procedures and standards that contribute to meeting internal SOP’s, regulatory and industry regulations.
- Maintains current knowledge of existing and emerging regulations, standards and laws.
- Administrative Responsibilities include attending all meetings (staff, core team, key one-on-one, multifunctional priority setting meetings, sustaining, etc.), reviewing and responding to emails and other messaging platforms.
Education
- Bachelor's Degree (Engineering, Biomedical or related field preferred), May have Master’s Degree, May have PhD
- 5-8 Years, Higher education may compensate for years of experience.
- Required
- Excellent communication, including verbal, technical writing, interpersonal and presentation skills.
- Proficient with technology applications such as MS Office,
- Experience with the creation of technical files and documentation
- Experience working in regulated medical device industry.
- Knowledge of ISO 13485, ISO 14971, ISO 9001, FDA and foreign regulatory requirements
- Strong data and statistical analysis skills and ability to use data to make informed recommendations
- High degree of attention to detail
- Beneficial
- Regulatory Affairs Certification (RAC)
- Project Management Experience
- FDA ESTAR experience
- Ability to appropriately assess written product and project documentation as the principal advocate for compliance, and ability to effectively communicate assessment
Program Manager, Regulatory Affairs
Olympus Corporation of the Americas -
Westborough, MA
