Senior Specialist, Regulatory Affairs

QUALIFICATIONS

 

Required:

 

• Bachelor's degree in science, engineering, or a related field
• 6 years Regulatory experience (medical device, pharmaceutical, and/or combination products)

 

 

Preferred:

 

• Previous direct experience interacting with regulatory authorities
• A strong knowledge of domestic and international regulations will be beneficial.

 

 

Skills & Competencies:

 

• Strong leadership and interpersonal skills.
• Strong experience with technical/scientific writing.
• Strong experience in developing and conducting presentations with Power Point and other key Microsoft programs.
• Excellent analytical and problem-solving abilities.
• Effective attention to detail in order to successfully oversee regulatory initiatives.
• Strong communication skills; and an ability to interface with regulatory authorities, suppliers and customers, as needed.
• Collaborate with colleagues and interface with suppliers, customers, and regulatory authorities as needed.
• Ability to work effectively cross-functionally and guide understanding of key Regulatory topics as an SME.
• Versed at developing metrics and implementing actions that make improvements in those metrics.

 

 

 

Physical Requirements:

• Must be able to remain in a stationary position for extended periods of time.
• Ability to consistently operate a computer and other office equipment, such as printer, telephone, etc.

 

 

RESPONSIBILITIES:

 

• Participate in Enable cross-functional teams as the Regulatory Affairs SME; provide regulatory strategy guidance, assess regulatory notification requirements of platform changes, etc.
• Represent Enable as the primary Regulatory Lead and Point of Contact for partner programs as necessary.
• Prepare responses to requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
• Recommend and implement changes to company procedures in response to changes in regulations or standards.
• Ensure compliance with regulations set by ISO 13485, 21 CFR 820, Medical Device Directive/Medication Device Regulations, and other key global requirements.
• Prepare and maintain master files, technical files, or other regulatory submissions as necessary to obtain and sustain finished product approval in the US and global markets.
• Prepare documentation needed to support investigational clinical studies conducted in the US (IND, IDE) or globally.
• Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
• Outline requirements for labelling, storage, and packaging.
• Support post-market surveillance obligations in accordance with applicable US and global regulatory requirements (