Title:  Sr. / Director, Regulatory Affairs

QUALIFICATIONS

Required:

• Excellent analytical abilities, strong communication skills in order to collaborate with colleagues and interface with suppliers and customers as needed.
• Effective attention to detail in order to successfully oversee regulatory initiatives.
• A minimum of 10 years of device design and development experience.
• Minimum of 10 years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
• Bachelor's degree in relevant field

Preferred:

• A strong knowledge of domestic and international regulations.
• Master’s in business or scientific discipline.

Skills & Competencies:

• Excellent analytical abilities, strong communication skills, and effective attention to detail
• Strong leadership and interpersonal skills.
• Ability to develop personnel through mentoring and coaching, both formally and informally, and most importantly by example.
• Versed at developing metrics and implementing actions that make improvements in those metrics.
• Experience in developing and conducting presentations with Power Point

RESPONSIBILITIES:

• Leads the Regulatory department and acts as the face of Enable in interactions with partners and regulatory authorities.
• Directs the workload and oversees the output of a team of regulatory professionals.
• Recommend changes to company procedures in response to changes in regulations or standards.
• Prepare or direct the preparation of master files and technical files as necessary to obtain and sustain product approval.
• Ensure compliance with regulations.
• Outlining requirements for labelling, storage, and packaging.
• Writing comprehensible, user-friendly, clear finished product artwork and labels.
• Oversees post-market work to ensure products remain in compliance once on the market.