Regulatory Affairs Professional 4
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Job Location:
Newton, MA - USA
Monthly Salary:
Not Disclosed
Posted on:
20 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Title -Regulatory Affairs Professional 4
Duration: 12 months-possible to extend
Location Newton MA 02466
Shift : 1st
Pay rate-on basis of exp-negotiable
Description:
As a Regulatory Affairs Specialist Consultant you will be responsible for:
Formulate and execute activities associated with regulatory submissions of a novel robotic medical device in the US market as well as markets outside of the US (e.g. Europe Asia).
In collaboration with subject matter experts independently prepare and author regulatory documents such as Design Dossiers Technical Files Device License Applications Investigational Device Exemptions (IDE) and pre-market notifications such as De Novo.
Support and manage interactions with regulatory bodies (e.g. FDA Notified Body)
Support Clinical Affairs (Research) in Clinical Evaluation Reports Post Market Surveillance Reports as needed. Lead the reporting of these technical documents to regulatory bodies as required by internal quality procedures.
Participate and support new product development teams by defining regulatory requirements for product development along with ensuring adherence to internal Design Control SOPs;
Support clinical affairs and clinical operations as needed (i.e. periodic reporting of safety to regulatory agencies)
Support document change control activities that require regulatory approval.
Review validation protocols and reports to support regulatory submissions.
Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the discipline as relevant to assigned projects.
Ensure compliance with regulatory agencies and all applicable standards worldwide for legacy and new products.
Work on complex challenges that require in depth knowledge of regulatory principles and practices.
Other duties as assigned.
Required skills to have for the success of this role:
Bachelors degree in a scientific discipline required Masters degree or higher preferred.
Minimum of 15 years experience in strategic Clinical and Regulatory Affairs tactical executions (including authoring regulatory submissions and demonstrating favorable outcomes such as regulatory approvals) a must;
Proficiency in ISOCFR820 (including Design Controls and Risk Analysis) EU MDR Regulation (EU) 2017/745 is a must.
Experience in medium to high-risk devices with along with De Novo or PMA applications and demonstrated approvals are a must.
Experience in generating updating and managing Clinical Evaluation Plans/Reports and Post Market Surveillance Plans/Reports is a must.
Experience with authoring and managing Technical Files and Design Dossiers conforming with Europes Medical Device Regulation is a must.
Proficiency and experience in rest of world regulatory submissions requirements for premarket approvals or clinical trial authorizations (e.g. Asia South America) are ideal.
Experience in project management and associated project management tools (e.g. Microsoft Project) is a must.
Knowledge and experience in clinical affairs including IDE submissions are ideal.
Experience with complex electromechanical software controlled robotic systems AI SaMD neuro devices is ideal
Experience with FDA inspection (QSIT) and Notified Body audits is required.
Experience with FDA BIMO inspection is ideal.
RAC-devices certificate preferred.
Ability and willingness to work in a lean fast-paced environment.
Willing to travel up to 5%.
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
