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Regulatory Affairs Specialist

Overall Summary:

Primary responsibility of the Regulatory Affairs Specialist is to support international registrations of Hemanext products and to ensure that applicable local, national and international regulatory requirements are met. The Regulatory Affairs Specialist also provides regulatory support to Product Development, Marketing, Quality, Clinical Affairs and international partners by gathering international requirements, reviewing and approving marketing literature and evaluating customer complaints for reportability supporting international registrations of product(s).

This position is based in Lexington, MA

Key Areas of responsibility:  

  • Works with international partners to develop comprehensive list of registration and licensing requirements.
  • Collects, compiles and prepares required materials for international registrations and works with international partners throughout the registration process. Maintains status of registrations.
  • Core team member of product development team; provides regulatory plans, prepares and/or supports preparation of US (510(k), Canadian licenses, and technical file and participates in all risk management activities
  •  Evaluates regulatory impact of proposed changes to launched product and ensures compliance with applicable regulations.
  • Reviews device labeling and marketing documentation to assess compliance with global regulations.
  • Maintains facilities registrations and device listings with the appropriate regulatory agencies.
  • Monitors changes to state, federal and industrial regulations and standards applicable to Hemanext and Hemanext products. Keeps organization informed of such changes. If applicable, prepares impact analysis of the changes or the new requirements and provide guidance and training.
  • Supports transition from EU Medical Device Directive (MDD) to Medical Device Regulations (MDR)
  • Prepares for and support third party audit and inspections, including Notified Body audits, FDA, other regulatory bodies and customers.
  • Supports the development and implementation of regulatory guidelines and tools to facilitate sustainable registration of products.
  • Reviews customer complaints for reportability and facilitate reporting when required.

Education and Experience Requirements:  

  • Bachelor’s degree in pharmacy, biotechnology, chemistry or other related science or technical field
  • Professional certifications (RAC) and/or Master’s degree desired
  • 5+ years medical device Regulatory Affairs experience or 3+ years medical device Regulatory Affairs experience and 2+ years of experience in related discipline (e.g. Quality, Clinical, Medical Affairs, Microbiology, biocompatibility or product development)
  • Submission experience including 510(k), international registrations, combination drug/device.

Behavioral and Interpersonal characteristics:  

  • Must be self-motivated, and possess strong organizational, time and project management skills,
  • Excellent written and verbal communication skills with the ability to interact at all levels of the organization and with external partners;
  • A positive, cooperative and team-player attitude is a must. Excellent business partnering skills;
  • Able to multi-task, meet tight deadlines, and prioritize changing demands in a fast-paced, entrepreneurial environment;
  • Requires high accuracy, thoroughness, and attention to detail ensuring that processes and protocols are always followed to minimize regulatory risks, strong analytical skills;
  • Ability to successfully interact with regulatory agencies through professional, articulate, and courteous conversations and clear, concise written communications;
  • Ability to work independently with limited supervision;
  • Willingness to continuously develop regulatory expertise.

To Apply → Please send your resume to careers@hemanext.com or apply through Linkedin.com.