Senior Regulatory Affairs Consultant

What we are looking for:

• Prepare US and OUS regulatory submissions: 510(k)s, IDEs, PMAs, Technical Files, and Design Dossiers

• Preform MDD and MDR Gap Analyses

• Review and assess changes to the design, manufacturing, and labeling for impact to product approvals/submissions

• Develop global regulatory strategies for new product introductions as well as existing product changes

• Act as regulatory representative on product development teams

What we offer:

• Competitive compensation, including 401(k) match, paid vacation and holidays

• Medical, dental, and life insurance

• Continued education, tuition reimbursement for career development courses

• Open and interactive office culture

• Lunch and beverages provided daily