Regulatory Affairs ( Medical Device)

 
**EASY APPLY on our Company Page with RESUME ONLY (Cover page optional). 


We are currently seeking a Regulatory Affairs Specialist to support the team in the development and execution of regulatory strategies.

If you have an outgoing personality, love to be a part of disruptive ideas and can work well with ambitious entrepreneurs that move at the pace out of this world, then this is where you belong!

Primary responsibilities may include:

  • Ensure compliance with pre- and post-market regulatory requirements, including assessment of product complaint reportability and submission of any Medical Device Reports.
  • Review routine change orders and product complaints for accuracy, effectiveness, and compliance.
  • Complete regulatory assessments for product and process changes and non-conforming material reports.
  • Maintain a database of standards, regulations, and FDA guidance documents.
  • Remain current with new and changing regulatory requirements in US, EU, Canada and ROW, communicate those requirements internally, assess impact on procedures and operations, and implement internal changes as necessary.
  • Support scheduled and unannounced notified body audits and FDA inspections. 

Must Haves: 

  • Develop and implement global regulatory strategies designed to : reduce product development cost/time; achieve faster-than-average review times with regulatory bodies
  • Review and approve protocols, reports, engineering drawings, procedures, labeling and other product development and manufacturing documentation to ensure compliance with regulatory requirements, consistency and accuracy
  • Provide direction and guidance to project teams to execute tactical regulatory affairs projects and/or initiatives.  
  • Includes preparation and oversight of larger documentation packages for submission to regulatory agencies. Track timelines and documents for inclusion in regulatory submissions.  
  • Interact with regulatory agencies as part of submission review and on-site audit support.
  • Identify and evaluate regulatory affairs process improvement and/or course correction/course alignment opportunities to accelerate route to market access in collaboration with key stakeholders.
  • Develop strategies and contingency plans for projects, including those that are most complex and challenging
  • Anticipate and advise on future regulatory trends and direction, and recommend preemptive approaches for company regulatory compliance
  • Key member in RA committee (e.g., AdvaMed, standards/committee) and provide input in the development of standards/regulations that affect the Medical Device industries.


Educational and Professional Requirements:

  • Bachelor’s Degree in Engineering, Science, or Healthcare related field.
  • Minimum of 2 years of medical device experience including knowledge of related US regulatory requirements OR a Master’s Degree in Regulatory Affairs with 0-2 years of related experience.
  •  5-7 years previous related experience, expert knowledge and understanding of global regulations relevant to Class III and/or Class III medical devices. 

 
About us:

We are not a large corporate consulting conglomerate, we are a small and steadily growing valuable consulting firm. -Valuable to our clients and consultants we work with. We have an excellent reputation with our clients and one that we continue to build upon. We are always looking for top talent.

 
**EASY APPLY on our Company Page with RESUME ONLY (Cover page optional). 

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