Sr. Regulatory Affairs Specialist #36964
Clinical Research
Lakewood, NJ Direct Hire Sep 10, 2024
Contemporary Staffing Solutions (CSS) is seeking a Senior Regulatory Affairs Specialist to join our client in Lakewood, NJ! The Senior Regulatory Affairs Specialist will be responsible for supporting New Product Development (NPD) initiatives and handling daily regulatory activities across multiple product platforms, with a focus on medical devices. This Direct-Hire opportunity offers up to $135,000/year!

Key Responsibilities:
  • Develop and execute regulatory strategies in line with global standards to support product development and regulatory submissions.
  • Lead interactions with US and international regulatory bodies, ensuring timely submission of regulatory documents and addressing inquiries or issues.
  • Oversee the preparation and submission of regulatory filings, including US FDA submissions, EU MDR, and other international filings.
  • Participate in the review and update of technical documentation and technical files to meet EU MDR requirements and support upcoming audits and certifications.
  • Review critical regulatory documents, including submissions and responses to regulatory agencies, ensuring accuracy and compliance.
  • Provide leadership and support to Regulatory Affairs Associates in managing submissions and ensuring successful approvals.
  • Develop and implement company and department-specific SOPs related to regulatory affairs, as needed.
  • Collaborate with cross-functional teams for NPD and sustaining product initiatives, ensuring regulatory compliance throughout the product lifecycle.
  • Perform additional duties as required to support the regulatory affairs function.

Qualifications:
  • Bachelor’s degree or higher in a scientific, engineering, or quality assurance discipline.
  • Minimum of 5 years of regulatory experience within a medical device or related industry, with a proven track record of obtaining regulatory approvals.
  • Regulatory Affairs Certification (RAC) or Master’s Degree in Regulatory Affairs is preferred and can count toward experience.
  • Strong knowledge of the European Medical Device Directive (MDD), Medical Device Regulations (MDR), and quality system standards.
  • Experience with technical documentation, post-market surveillance, and participation in design teams.
  • Proficient understanding of 21 CFR 820, ISO 13485, and MDSAP compliance standards.

Contemporary Staffing Solutions (CSS) has been a leading provider of contract, temporary, temporary-hire & direct hire solutions. We began as a staffing agency and evolved to a national provider of workforce management solutions with a niche recruitment focus in Accounting & Finance, Call Center & Office, Human Resources, Sales & Marketing, & Information Technology. To learn more about CSS, visit our website: www.ContemporaryStaffing.com.