Regulatory Affairs Professional 4

Overview :

TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients world-wide The opportunity below is with one of our clients a leading global medical technology company. This organization provides a wide range of diagnostic imaging and laboratory diagnostics as well as advanced therapies and digital health services. Its solutions span prevention and early detection through diagnosis treatment and follow-up care empowering healthcare providers worldwide.

Job Title : Regulatory Affairs Professional 4

Location : Newton MA 02466

Duration : 12 Months

Job Type : Temporary Assignment

Work Type : Onsite

Shift : 8.00AM-5.00PM

Job 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 :

TekWissen Group is an equal opportunity employer supporting workforce diversity.

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Employment Type : Full Time

Experience : years

Vacancy : 1