Senior Regulatory Affairs Specialist
Merit Medical Oncology
full-time
Posted on:
Location Type: Remote
Location: California • United States
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Job Level
About the role
- Determines global regulatory pathways for various projects including product classification and type of regulatory submission or rationale required.
- Participates on various teams to define regulatory requirements of U.S. and international submissions, Technical Files or regulatory rationales.
- Identifies guidance documents, international standards, Consensus Standards and assists teams with their interpretation.
- Prepares regulatory submissions to the FDA, the Notified Body and other regulatory authorities.
- Prepares IDEs and PMAs and assists with clinical trials when required.
- Interacts with various levels of management, external agencies and companies.
- Analyzes and makes recommendations regarding field complaints.
- Develops, maintains and analyzes department systems and provides training when needed.
- Remains current on developing regulations and revises systems as necessary.
- Participates in and assists with FDA facility inspections, Notified Body Audits and other inspections and audits as directed.
- Assists with supervision of department staff, as directed.
- Performs other related duties and tasks, as required.
Requirements
- Education and/or experience equivalent to a Bachelor's Degree in a technical field such as the biological, physical, engineering or material science disciplines and six years of related industry experience.
- Demonstrated knowledge of U.S. FDA regulations, the Medical Devices Directive (93/42/EEC, as amended), and various Quality System Standards/Regulations/Laws, including but not limited to ISO 13485, etc.
- Demonstrated and verifiable experience with authoring regulatory submissions and interacting with reviewers.
- Self-motivated, self-directing, strong attention to detail and excellent time management skills.
- Strong interpersonal skills and the ability to communicate well – verbally and in writing – with others.
- Demonstrated computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs.
Benefits
- Medical/Dental & Other Insurances (eligible the first of month after 30 days)
- Low Cost Onsite Medical Clinic
- Two (2) Onsite Cafeterias
- Employee Garden | Gardening Classes
- 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays
- 401K | Health Savings Account
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory submissionsproduct classificationIDE preparationPMA preparationclinical trialsfield complaint analysisregulatory requirementsguidance document interpretationQuality System StandardsISO 13485
Soft Skills
self-motivatedstrong attention to detailexcellent time managementstrong interpersonal skillseffective communication