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:

• Bachelor s degree in a scientific discipline required Master s 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 Europe s 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%.

TekWissen Group is an equal opportunity employer supporting workforce diversity.