Light Industrial

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Regulatory Affairs Specialist

Milford, MA

Employment Type: Full Time Industry: Light Industrial Pay Rate: $30-$35 Specialty: BioTech/Pharmaceuticals Branch: Worcester, MA Pay Type: Hour

Job Description

New Product Development – 60%

  • Act as Subject Matter Expert (SME) and Regulatory Affairs lead for the new product development projects, provide "solution-based" advice to development teams
  • Develop and maintain regulatory strategies for new and modified product / product families
  • Prepare and execute regulatory filings such as pre-IDEs, premarket notifications, technical files, Canadian submissions, and letters to file.
  • Conduct international registrations following and in support of regulatory strategies
  • Provide input on and approve product labels and labeling including language requirements worldwide.
  • Support set up and management of outside vendors such as License holders and In Country agents [including importers, and distributors], as needed.
  • Perform regulatory research to find predicate and support new product development as needed

Change Management – 20%

  • Provide regulatory guidance on changes to existing products.
  • Monitor global regulatory intelligence and provide impact evaluation to changing regulations.
  • Performing regulatory impact assessments for engineering changes
  • Review and approve promotional materials, 

Post Market – 10%

  • Provide regulatory input to support post market surveillance and vigilance activities.
  • Support Health Hazard Assessments and Field Actions as needed.

Leadership – 10%

  • Support generating a strong Quality culture within the Clinical Business Unit through effective collaboration with peers.
  • Act as Subject Matter Expert within 3rd party and internal audits.
  • Manage and maintain Regulatory Affairs internal policies and procedures.
  • Guide regulatory specialists as needed to support regulatory and/or clinical strategy requirements.

Job Requirements

  • Bachelor’s degree required preferably in Analytical Chemistry, Biochemistry, or Biomedical Engineering. Graduate education is preferable.
  • Experience in Asia Pacific (APAC) IVD regulations.

Additional Information

At HW Staffing Solutions we recognize the value of our employee associates as equally as our clients. We are passionate about people and improving the lives of every associate, we do this by connecting you with great companies and great opportunities. We celebrate our awesome diversity, believe that everyone has a unique talent, and appreciate the passion and perspectives that each of us bring to the table. Discover a new way to work together with a company that is focused on offering the best opportunities, benefits and career advancement in Accounting & Finance, Office & Administrative, Light Industrial, Professional & Technical, Call Center, Food Processing and Hospitality. HW Staffing Solutions is an Equal Employment Opportunity company.

Meet Your Recruiter

Josie Erdmann
Sr. Staffing Specialist

My name is Josie and I am a Sr. Staffing Specialist out of our Sutton branch. I have been with HW Staffing for 6 years totaling a total of 10 years within the Staffing Industries. 

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