Education and Experience, or Equivalent
10 - 14 Years with BA, 8 - 12 Years with MBA

Preferred Qualifications
Candidate should have strong experience in the combination products space, particularly dealing with CMC sections and CDER.

Additional requirements and responsibilities unique to this position:

· Primary responsibility involves obtaining and/or maintaining CRM product approvals and may include the review of Engineering Change Orders, review of advertising and promotional materials, authorizing of PMA Annual Reports, and submitting of Pre-IDE, sPMA, PMA, or 510(k) submissions to the FDA.
· Comfort with technical material including interfacing with clinical, software, electrical, and mechanical functional areas.
· Ability to coordinate multiple, diverse work streams simultaneously
· Previous history of quickly developing new competencies
· Excellent communication skills with demonstrated competence and confidence in organizing and presenting compelling proposals for internal and external audiences
· Previous US Drug Regulations or Combination Products preferred
· Previous PMA submission experience preferred

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification.They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.

Job Experience:
Education and Experience, or Equivalent
10 - 14 Years with BA, 8 - 12 Years with MBA

Preferred Qualifications
Candidate should have strong experience in the combination products space, particularly dealing with CMC sections and CDER.

Additional requirements and responsibilities unique to this position:

· Primary responsibility involves obtaining and/or maintaining CRM product approvals and may include the review of Engineering Change Orders, review of advertising and promotional materials, authorizing of PMA Annual Reports, and submitting of Pre-IDE, sPMA, PMA, or 510(k) submissions to the FDA.
· Comfort with technical material including interfacing with clinical, software, electrical, and mechanical functional areas.
· Ability to coordinate multiple, diverse work streams simultaneously
· Previous history of quickly developing new competencies
· Excellent communication skills with demonstrated competence and confidence in organizing and presenting compelling proposals for internal and external audiences
· Previous US Drug Regulations or Combination Products preferred
· Previous PMA submission experience preferred

Minimum Education Required: Bachelor

Years of Experience Required: More than 5 years

Expected Travel Time: None

This company may offer relocation assistance.