What are the responsibilities and job description for the Senior Specialist, Regulatory Affairs position at Enable Injections, Inc.?
Title: Senior Specialist, Regulatory Affairs
Description
QUALIFICATIONS
Required
Description
QUALIFICATIONS
Required
- Bachelor's degree in science, engineering, or a related field
- 6 years Regulatory experience (medical device, pharmaceutical, and/or combination products)
- Previous direct experience interacting with regulatory authorities
- A strong knowledge of domestic and international regulations will be beneficial.
- 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.
- 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.
- 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 (including MDR).
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