Regulatory Affairs Specialist Consultant

Are you a Regulatory Affairs Specialist Consultant who is looking to join one of the top companies within the Manufacturing industry?

Are you looking to further your career and grow?

Do you have experience in strategic Clinical and Regulatory Affairs tactical executions (including authoring regulatory submissions and demonstrating favorable outcomes such as regulatory approvals)?

If you answered yes to those three questions, then apply today!

Acara Solutions is seeking highly qualified candidates to work onsite with our client in Newton, MA. Interested?

Here's what you'd do:

• Formulate and execute activities associated with regulatory submissions for a novel robotic medical device in the US market, as well as in international markets (e.g., Europe, Asia).
• In collaboration with subject matter experts, independently prepare and author regulatory documents, including Design Dossiers, Technical Files, Device License Applications, Investigational Device Exemptions (IDEs), and pre-market notifications, such as De Novo submissions.
• 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 needed 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.

Here's what you'll get:

• Pay rate: $68.89/Hour.
• Hours: 40 Hours/Week 1^st Shift
• Length: Temp (12 Months)

Sound like a good fit?

APPLY TODAY

About Acara Solutions

Acara is a premier provider of recruiting and workforce solutions, and we help companies compete for talent. With a legacy of needs in various industries worldwide, we partner with clients, listen to them, and customize visionary talent solutions that drive desired business outcomes. We leverage decades of experience to deliver contingent staffing, direct placement, executive search, and workforce services worldwide.

• Bachelor's Degree
• Minimum of 15 years of experience in strategic Clinical and Regulatory Affairs tactical executions (including authoring regulatory submissions and demonstrating favorable outcomes such as regulatory approvals)
• Minimum of 15 years of experience in medium to high-risk devices, along with De Novo or PMA applications, and demonstrated approvals
• Minimum of 15 years of experience in generating, updating, and managing Clinical Evaluation Plans/Reports and Post Market Surveillance Plans/Reports
• Minimum of 15 years of experience with authoring and managing Technical Files and Design Dossiers conforming to Europe's Medical Device Regulation
• Minimum of 15 years of experience in project management and associated project management tools (e.g., Microsoft Project)
• Minimum of 15 years of experience with Food and Drug Administration (FDA) inspection (Quality System Inspection Technique (QSIT)) and Notified Body audits

• Master's Degree
• Proficiency in ISO 13485, 21CFR820 (including Design Controls and Risk Analysis), EU MDR Regulation (EU) 2017/745
• Proficiency and experience in the rest of the world's regulatory submissions requirements for premarket approvals or clinical trial authorizations (e.g., Asia, South America)
• Knowledge and experience in clinical affairs, including Investigational Device Exemption (IDE) submissions
• Experience with complex electromechanical, software-controlled robotic systems, Artificial Intelligence, Software as a Medical Device (SaMD), and neuro devices
• Experience with Food and Drug Administration (FDA) Bioresearch Monitoring Program (BIMO) inspection
• RAC-devices certificate.
• Ability and willingness to work in a lean, fast-paced environment.

Additional Information :

• Upon offer of employment, the individual will be subject to a background check and a drug screen.
• In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
• Willing to travel up to 5%.