Director of Regulatory Affairs

Neuspera® Medical is seeking a senior level candidate with regulatory affairs experience.

PRIMARY FUNCTION:

The qualified candidate will have strong experience in providing regulatory support for Class III medical devices on a global basis including experience with the Food and Drug Administration, Competent Authorities, Notified Bodies and European Authorized Representatives. The qualified candidate will work with the SVP and Executive Team to develop the Regulatory Strategy for the Company.

Base Pay

Employment Type

Negotiable

Full-Time

Job Type

Regulatory Affairs

Education

BS Degree; MS Preferred

Experience

>10 years

Manages Others

Not initially

Industry

Medical Devices

Required Travel

Up to 20%

 

JOB DUTIES:

  • Prepare FDA submissions (Q-Subs, IDEs, PMAs) and negotiate timely approval for clinical trials and market release of products
  • Work with outside vendors to publish the regulatory submissions to ensure acceptance with regulatory agencies
  • Write regulatory justifications to support submission filing decisions
  • Ensure regulatory submissions are truthful, accurate and verified against source documents to ensure compliance and traceability
  • Work with the SVP on submission discussions with the FDA and other global regulatory agencies, engaging engineers and leadership within the company as appropriate
  • Work closely with engineers and technical experts, to translate regulatory requirements into product requirements ensuring products are developed according to appropriate international standards (ISO and IEC) and guidance documents for chronic implantable Class III medical devices
  • Review product changes for regulatory impact ensuring compliance with appropriate global regulations
  • Review clinical protocols for regulatory compliance
  • Support regulatory compliance including updates to the quality system, development of SOPs, manufacturing site registration, support of ISO 13485 registration, and regulatory audits
  • Responsible for staying up to date with the changing worldwide regulatory requirements including proficiency with the European Medical Device Regulation
  • Interface with Marketing to provide regulatory review of claims and messages in support of overall marketing projects
  • Contribute to a goal oriented collaborative productive work environment

The ideal candidate will have experience in all the above areas with an implantable medical device application background.

JOB REQUIREMENTS

Qualifications and Experience:

  • Bachelor’s degree in a scientific field, B.S. or (MS or PhD) in Biomedical Engineering is a plus
  • Demonstrated experience in medical device product development with at least 10 years of experience as a regulatory affairs professional
  • Results driven, collaborative team player capable of working well with others
  • Strong verbal and medical writing communication skills

Work Environment:

To apply send your resume to: careers@neuspera.com