A strong knowledge of domestic and international regulations is beneficial
Master’s degree or higher in a scientific discipline
Regulatory Master’s or RAC
Strong technical background
Skills & Competencies
Excellent analytical abilities; strong communication skills; and an ability to interface with regulatory authorities, suppliers and customers, as needed
Effective attention to detail in order to successfully oversee regulatory initiatives.
Strong leadership and interpersonal skills.
Experienced in technical/scientific writing
Experienced in developing and conducting presentations with Power Point and other key Microsoft programs
Physical Requirements
Must be able to remain in a stationary position for extended periods of time
Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.
Responsibilities
Support cross-functional team deliverables and activities, including regulatory submissions.
Assist the project Regulatory Lead to execute deliverables
Perform literature-based research to support regulatory submissions and post-market activities.
Prepare responses to Enable Injections Customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires;
Write technical summaries
Assist in the preparation of master files, technical files, or other regulatory submissions as necessary to obtain and sustain finished product approval in the US and global markets;
Assist in the preparation of documentation needed to support investigational clinical studies conducted in the US and globally
Develop knowledge of Quality System (ISO 13485, 21 CFR 820, 21 CFR Part 4) requirements and domestic and international regulatory framework
Assist Regulatory Lead on post-market surveillance obligations in accordance with applicable US and global regulatory requirements (including MDR).
Enjoy a collaborative and innovative culture with competitive pay and full benefits package.
Seniority level
Entry level
Employment type
Full-time
Job function
Other
Industries
Motor Vehicle Manufacturing
Referrals increase your chances of interviewing at Enable Injections, Inc. by 2x