Regulatory Affairs Associate
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Job Location:
Scottsdale, AZ - USA
Monthly Salary:
Not Disclosed
Posted on:
11 hours ago
Vacancies:
1 Vacancy
Job Summary
The Regulatory Affairs Associate role is responsible for assisting with preparing and submitting the appropriate documentation for pre-market submissions (i.e. FDA 510(k) submissions Health Canada Device License Applications). This role also supports post-market regulatory compliance activities.
Role and Responsibities:
- Assisting with responses to deficiency letters and other requests for documentation for submissions.
- Reviews complaints/adverse events for submission of MDRs;
- Review and approve test protocols/reports and other documentation/information for regulatory submissions from various functional areas and check for errors legibility and missing information;
- Assist with the development of labeling and ensure compliance with applicable regulations;
- Participate in project development teams and review plans reports risk management risk assessments and design reviews associated with product and process projects;
- Provide regulatory assessments for manufacturing line extensions design changes and validation activities;
- Conduct regulatory review and approval of change orders and related project documentation;
- Implement and maintain unique identifier (UDI) activities for compliance;
- Assists with PFMEA risk assessments;
- Assists in archiving regulatory documentation and maintaining related databases;
- Participate in internal and external audits;
- Assist with other Regulatory projects and activities as required.
Education and Qualifications:
- Minimum of Bachelors degree (preferably in (i.e. Engineering Biological Sciences or other technical field) or equivalent education training and experience;
- Minimum of one (1) year medical device regulatory and/or quality experience;
- Basic knowledge of FDA 21 CFR Part 820 ISO13485 and 510(k) submission requirements preferred;
- Basic knowledge of Canadian Medical Device Regulations MDD MDSAP and ISO standards preferred;
- High degree of initiative be able to balance a variety of tasks and with strong organizational abilities;
- Strong commitment to quality accuracy and detail;
- Excellent oral & written communications skills;
- Excellent interpersonal skills are required due to the numerous internal customers with varying and unique requirements/ priorities. Must understand the nature of the work and the impact it has on the organization.
- Ability to work in a fast paced/entrepreneurial team environment;
- Proficient in computer applications (i.e. Microsoft Office Word PowerPoint Excel etc.)
Required Experience:
IC
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
HEALTHCARE NEEDS NEW ANSWERS Hospitals in the US are financially fragile and the pandemic has brought many to the verge of bankruptcy. Meanwhile, advancements in pharmaceuticals and medical technology carry the promise of better patient care – and a hefty price tag that threatens the ... View more
