Director, Regulatory Affairs - Compliance Systems and Labeling

Job Overview

Join our dynamic team where you'll direct regulatory and labeling activities for a leading global medical device company. Collaborate with senior teams to define strategy and compliance programs, playing an integral role in launching new products and supporting established lines. If you thrive on strategic influence and want to champion quality and compliance on a global scale, we want to connect with you.

Duties and Responsibilities

• Provide strategic direction and operational leadership for regulatory affairs and global labeling.
• Develop and communicate effective regulatory strategies to meet established business goals.
• Champion quality and regulatory initiatives aimed at improving business systems and compliance.
• Work closely with senior colleagues to resolve complex and sensitive issues.
• Foster proactive relationships with internal teams including R&D, Clinical, Scientific, Quality, Legal, Manufacturing, and Marketing.
• Direct the professional growth of staff by providing guidance, training, and supervision.
• Participate in management teams and oversee regulatory submissions and compliance programs.
• Act as the primary interface with regulatory bodies and ensure all activities are conducted ethically and legally.
• Support the development of new products from design to validation.
• Identify regulatory or compliance risks and develop mitigating strategies.
• Monitor and drive solutions for changes in the regulatory environment.

Minimum Qualification Requirements

Education

• Four-year college degree required; an advanced degree in physical sciences is a plus.
• Professional education in Regulatory Sciences desired with regulatory certification a plus.

Experience

• Minimum of 10 years of regulatory experience in the medical device or pharmaceutical industry.
• Experience with sterile disposables and electro-mechanical medical devices preferred.
• Knowledge of software in medical device regulations preferred.
• Experience with pharmaceutical or medical device submissions.
• Minimum 5 years of managerial experience with multiple direct reports.
• Demonstrated leadership and strategic planning skills.
• Experience working closely with clinical experts in clinical trials.
• Experience in regulatory compliance requirements desired.
• Direct experience in business and management principles.
• Experience working in Quality or leading a Quality team is preferred.

Skills

• Ability to solve practical problems and interpret complex regulatory requirements.
• Demonstrated ability to manage, motivate, and develop regulatory skills in coworkers.
• Capacity to define and communicate regulatory challenges and solutions.
• Excellent written and oral communication skills.
• Ability to interact productively and influence peers and senior management.
• Willingness to take ownership and accept responsibility for actions and decisions.
• Regulatory expertise complemented by strong operational and business skills.
• Knowledge of current US and non-US regulatory requirements.
• Strong interpersonal and conflict management skills.
• Detail-oriented and well-organized, able to work independently and in teams.

Certificates, Licenses, Registrations

Regulatory Affairs Professional Society (RAPS) Certification or other geographic regulatory certification preferred.

Location

Lakewood, Colorado - Onsite (hybrid) - Open to candidates willing to relocate to the area.

Travel

• Some international travel required (10-15%).
• Occasional requirement to work outside of normal business hours.

Physical Requirements

• Typical office environment requirements include reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Compensation

Target Pay Range: $196,500.00 to $245,600.00 - Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data.

Target Bonus on Base: 30.0%