Senior Regulatory Affairs Specialist, Sustaining Contractor

Company: Regulatory and Quality Solutions LLC (R&Q)
Location: Marlborough
Posted on: April 6, 2025

Job Description:

RQM+ is the leading MedTech solutions partner, accelerating the product lifecycle from innovation to patient impact. While manufacturers create medical technology, we apply our end-to-end expertise to propel products from concept through market entry and ongoing post-market support.Our tailored solutions bring unmatched regulatory and quality expertise, FDA-recognized laboratory and materials science, comprehensive clinical trial design and execution, and impactful reimbursement strategies - accelerating market entry and commercial growth. We partner closely with manufacturers across device types and therapeutic areas to deliver life-changing technologies to patients: faster, safer, better.We don't make MedTech. We make MedTech happen.6 Months ContractHybrid - Onsite 2-3 Days a WeekThe Senior Regulatory Affairs Specialist will provide regulatory support on a range of Endoscopy devices and activities which include evaluation of post market design changes, international submission support, commercial, manufacturing, & compliance support as well as other responsibilities aligned with global medical device regulations and goals of the business.Responsibilities:

• MDR Sustaining support related to PSUR, SSCP, and/or Sampling Plan submissions.
• Leading Core Team meetings to collaborate cross-functionally on PSUR, SSCP, and Sampling Plan submissions.
• Approving change notices for documentation updates required to submit to Notified Bodies.
• Prepping and submitting documentation submission package to Notified Body.
• Act as primary contact to Notified Body for any product submission questions.
• Reviews and collaborates with design, clinical, and manufacturing teams on responses to questions from EU regulatory bodies related to compliance to the EU Medical Device Regulation.
• Regulatory Sustaining product support.
• Active engagement in product / project team meetings.
• Review, recommend appropriate changes, and approve product change notices.
• Prepare and submit regulatory documentation and applications, as applicable.
• Review device labeling and advertising materials for compliance with submissions and applicable regulations; analyze and recommend appropriate changes.
• Review and approve product and manufacturing changes for compliance with regulatory requirements.
• Design History File documentation creation, updates, and approval within the Boston Scientific documentation management system.
• Support and maintain Quality initiatives in accordance with Quality Policy.
• Continuously assess ways to improve Quality.Requirements:
  • Bachelor's degree or equivalent work experience, preferably in a scientific or technical discipline.
  • 5 + years Regulatory Affairs experience, medical device industry experience required.
  • Working knowledge of FDA and international regulations for medical devices.
  • General understanding of product development process and design control.
  • General understanding of regulations applicable to the conduct of clinical trials.
  • Ability to manage several projects of moderate scope and complexity.
  • Proficiency with Microsoft Office.
  • Effective research, analytical, and problem-solving skills.
  • Effective written and oral communication, technical writing, and editing skills.
  • Ability to work independently with minimal supervision.Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today!We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.
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Keywords: Regulatory and Quality Solutions LLC (R&Q), Boston , Senior Regulatory Affairs Specialist, Sustaining Contractor, Other , Marlborough, Massachusetts