Director of Regulatory Affairs (DOE) - Global

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 Director of Regulatory Affairs (DOE) – Global with a starting range of $190,000 - $225,000/year, dependent upon experience, education, and skills. This role is eligible for a hybrid schedule of work from home/office.

The Director of Regulatory Affairs will work with cross-functional department leadership to build and execute regulatory strategies across the globe. They will oversee regulatory programs and ensure both maintenance and new country introductions are conducted in a timely manner. This role has direct reports.

Key Responsibilities

• Develop global regulatory strategies using least-burdensome pathways in regions such as:

  • United States

  • Brazil/Latin America

  • Japan

  • Europe (MDD/MDR)

  • United Kingdom

  • Canada

  • Australia

  • Other countries as designated by strategic planning

• Review, assess and improve the suitability of the Quality Management System (QMS) for regulatory processes such as:

  • US FDA: (510(k), PMA, HUD/HDE, IDE, De Novo Classification Request and FDA Section 520(b) Devices, and Human Cell and Tissue Products (HCT/P))

  • EU: MDR Class 1R, IIa, IIb, III

  • UKCA

  • Health Canada

  • PMDA (Japan)

  • TGA (Australia)

  • Support other countries as necessary (e.g. South Africa, Chile, etc.)

• Oversee the submission of regulatory applications for the applicable pathways shown above, utilizing internal and external resources

• Build and maintain technical strategies for new country introduction and maintain ongoing compliance to the relevant regulations

• Develop and maintain organizational strategies to support domestic and international business objectives

• Ensure accurate classification and execution of essential principles, essential requirements, and general safety and performance requirements

• Maintain compliance to policies and procedures for product changes and surveillance

• Schedule and collaborate with Notified Bodies and local regulators

• Manage in-country representatives to support continued product compliance

• Support internal and external audits such as ISO 13485, MDSAP, and product surveillance audits

• Oversee domestic and international regulatory applications, budget and schedule

• Oversee compliance of labeling, translations, and promotional activities

• Oversee management of Customs process and required reporting

• Oversee authoring of clinical documents to support company pre- and post- market clinical data requirements

• Oversee the evaluation of changes to cleared devices and determination of next steps, new domestic or international filings, letter-to-file or other required amendments

• Oversee maintenance of US and international product registry databases (e.g. GUDID, EUDAMED, etc)

• Identify and/or resolve technical issues to support global regulatory initiatives

• Collaborate with departmental leadership to navigate and establish regulatory prioritization based on direction from executive management

• Understand regulatory concepts and present/train cross-functional departmental staff on compliance (clinical, quality, engineering, marketing, etc.)

• Must have a strong familiarity with a variety of regulatory bodies (US FDA, EU/UK, TGA, Health Canada, etc.)

• Demonstrate computer literacy

• Build, mentor and manage the regulatory team to support product release and ongoing compliance

• Develop, actively manage, and report on department budget

• Other tasks as directed by management

Travel

Up to 10% of overnight travel may be required.

Qualifications

• Requires a minimum of a bachelor’s degree and at least 10 years of relevant experience.
• RAC (desired)
• Past leadership and management experience managing regulatory teams
• Knowledge of EU MDD 93/42 EEC and EU MDR 2017/45
• Knowledge of ISO 13485:2016
• Knowledge of 21 CFR Part 8xx device regulations
• MSDSAP Experience
• Advanced knowledge of the orthopedic industry preferred
• Knowledge of applicable guidance documents (FDA, IMDRF, GHTF) used to support regulatory submissions
• Knowledge of applicable external consensus standards (ASTM, ISO, AAMI, etc.) used to support regulatory submissions
• Must have a strong familiarity with a variety of regulatory bodies (US FDA, TGA, Health Canada, etc.)
• Fluent in Word, Excel, PowerPoint, Outlook

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 : $190,000 - $225,000