Regulatory Affairs Specialist II

Description

Paragon 28’s growth continues and we’re looking for more great employees!  Now is your chance to join this public company dedicated to improving a patient’s quality of life with the treatment of the most challenging foot and ankle conditions!  We are currently looking to fill the position of Regulatory Affairs Specialist II with a starting range of $70,000 - $87,000/year, dependent upon experience, education, and skills.  This position may have the opportunity for occasional work from home.

The Regulatory Affairs Specialist II collaborates with the Regulatory Affairs, Engineering, and Quality teams to ensure compliance with all regulatory requirements for Paragon 28 products distributed in the United States, Canada, and other territories/regions as assigned. This position is responsible for regulatory strategies, submissions, and communication with government agencies (e.g. FDA, Health Canada), as well as regulatory assessments and reviews of quality management system documents.

Key Responsibilities

• Review and understand global regulatory requirements (FDA, TGA, EU MDD, EU MDR, Health Canada, etc.)

  • Maintain compliance to FDA UDI requirements

• Assemble and maintain regulatory files (510(k) submissions, STED, Technical Files, etc.)

  • Assist engineering in implementing verification and validation strategies

  • Work with regulators to release products into new or established markets

  • Review and establish predicates for FDA premarket notifications

  • Review competitive literature to develop regulatory strategies

• Support project teams in decisions that affect regulatory compliance

• Review marketing literature for regulatory compliance

• Registration and listing of devices

• Create and maintain product labeling

• Knowledge of GMPs

• Other duties as assigned

Travel

10% of overnight travel.

Qualifications

• Bachelor’s degree in a technical field (Engineering, Biology, or Regulatory Science) and 3-7 years of regulatory experience; or equivalent combination of education and experience.
• Knowledge of 21 CFR Part 820, EU MDD 93/42/EEC, EU MDR 2017/745, and ISO 13485
• Understanding of orthopedic and/or implantable devices; previous medical device industry experience required
• History of working collaboratively across functions
• Excellent attention to detail and proven organizational skills, able to prioritize and multi-task and see projects/assignments to completion
• Proficiency in Excel, Word, PowerPoint, Outlook and customer database management systems
• Proficiency with FDA’s eSTAR submission tool
• Proven leadership and negotiation skills, works well with all levels, able to successfully manage cross-departmental expectations
• Excellent written and verbal communication skills

P28 is a leader in the development and distribution of medical solutions for the foot and ankle industry.  Established in 2010, every member of our inspired and dedicated team serves a vital role in the achievement of our mission: to strategically build a company around the core principles that drive innovation and quality.  We're located at 14445 Grasslands Dr., just off E-470 and Peoria St. on the east side of Englewood, CO.

We offer comprehensive medical coverage with generously subsidized premiums for both employees only and coverage with dependents. Plans include prescription drug and behavioral health coverage as well as telemedicine services.  Additional options for dental and vision benefits, life and disability coverage, flexible spending accounts, supplemental health protection plans (accident, critical illness), pet insurance and more.  Free counseling services and resources are offered for emotional, physical, and financial wellbeing through our Employee Assistance Program.  A safe harbor 401(k) Plan with 3% match and an Employee Stock Purchase Plan, which allows purchase of P28 stock at a discounted rate.  You are able to accrue 19 days of PTO over 12 months to maintain a fulfilling work/life balance. Our working environment is considered Colorado Casual. Onsite we have a fresh food kiosk, free parking and will have a new, expanded fitness center!

Paragon 28 is an equal opportunity employer and values diversity. All employment decisions are decided on the basis of qualifications, merit, and business need.

Notice to Recruiters and Staffing Agencies:  to protect the interests of all parties, Paragon 28, Inc. will not accept unsolicited resumes or referrals from any source other than directly from a candidate or an approved vendor that has a written and signed agreement in place through the Paragon 28, Inc. HR department.  Please do not contact or forward resumes or referrals to our company employees.  Any unsolicited resumes will be considered Paragon 28, Inc. property.  Paragon 28, Inc. is not responsible for any charges or fees related to unsolicited resumes or referrals.

Salary : $70,000 - $87,000