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Regulatory Affairs Consultant (Medical devices)

Employer
Parexel
Location
Bucharest, Romania
Salary
Competitive
Start date
25 Feb 2021
Closing date
27 Feb 2021

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Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Job Description

A Regulatory Affairs Consultant must have an understanding of the organization's consulting models and methodologies, as well as, good knowledge of what services PAREXEL Consulting provides. A Regulatory Affairs Consultant must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market. A Regulatory Affairs Consultant ensures the timely performance of work within a project scope to the quality expectations of PC and the client. When serving as a Project Technical Lead, a Regulatory Affairs Consultant assures the work of the entire team is delivered on time and that it meets client's and PC's quality expectations.

We are currently looking for a Regulatory Affairs Consultant who will have the following responsibilities:

• Lead and manage review and approval of SDLC deliverables in accordance with Software as Medical Device and Design Controls procedures.
• Review and approve plans, requirements, protocols and reports generated as part of the software development process. Determine and enforce quality and safety requirements in accordance with company needs and ensure compliance to design control procedures.
• Represent Device Quality on cross-functional teams in support of SDLC activities
• Act as subject matter expert in developing and revising validation documents ensuring compliance with regulatory requirements
• Lead and facilitate Risk Assessment (Design (system) FMEA) and Mitigation. Review and approve risk management documents
• Provide guidance and support to device development/testing team in their verification (system, UAT) and validation (Human Factors Formative Study) efforts, to ensure compliance.
• Review and approval of adjudicated issues (e.g. deviation, investigations) and technical matters (e.g. design changes, verification and validation) with impact to design control and risk management
Qualifications

• Good understanding of performing the above regulatory tasks on a global level
• Proficiency in system development lifecycle activities and documentation
• Either experience in Software development activities and or Computer system validation
• Experience in ISO 13485 and IEC 62304
•FDA 21 CFR Part 820 with good understanding of quality system, tools and practices
• Very good project Management skills
• Proactive approach and excellent communication skills
• Fluent English and RomanianWhy Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

Company

Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, Parexel has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Parexel Informatics, Inc., a subsidiary of Parexel, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.

 

Mission: Parexel’s mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.

 

Company info
Website
Telephone
+44 1895 238000
Location
The Quays
101-105 Oxford Road
Uxbridge
Middx
UB8 1LZ
GB

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