Alston

FDA Technical Consultant

Washington DC · Senior

Sponsorship not specified$200k-$250kDetected 31 days ago

Customer SupportGMPFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationOrganizational Skills

About the role

Our company culture has earned us one of the "100 Best Companies to Work For" for 27 consecutive years.
This honor, along with many others, highlights our commitment to innovation and professional development.
At Alston & Bird LLP, our foundation is made of trust, reliability, and compassion.

Provide technical support for remediation efforts in response to Form FDA 483s, Warning Letters, and other enforcement actions
Collaborate with cross-functional teams at the Firm and at the client including legal, regulatory, quality, manufacturing, and executive leadership teams
Maintain current and accurate daily time record
Perform special projects as assigned
Work typically requires more than 40 hours per week to perform the essential duties of the position; may require irregular hours.
Ability to provide exceptional client service and manage multiple engagements in a fast-paced environment.
Willingness to frequently travel to international and domestic client sites to support inspections, audit, and remediation activities.

Ability to travel to private and public buildings, domestically and internationally, via private or public conveyance to assist attorney in attending to client needs on legal matters.
Bachelor's degree in chemistry, biology, pharmacy, engineering, or a related field.
FDA experience required.
Minimum of 5 years as an FDA investigator or compliance officer, or industry senior position in global quality assurance.
In-depth knowledge of quality systems, regulatory requirements (21 CFR Parts 210, 211 and related guidance), quality management systems (QMS), and ISO standards.

Regular travel within the United States and Internationally. Regular travel 1-2 weeks a month with flexibility for more.
Ability to organize and prioritize numerous tasks and complete them under time constraints.

The salary range for this position in Washington D.C. is $200,000-$250,000 and represents the firm's good faith minimum and maximum range for this role at the time of posting.
The actual salary offered will be dependent on various factors, including but not limited to, the candidate's experience, education, relevant certifications, geographic location, market demands, and specific business needs.
Generally, candidates are considered for the higher end of the salary range when they bring the requisite level of experience and expertise to the role.

As a leading international law firm, we are dedicated to excellence through impactful communication, collaboration, and community involvement.

Alston & Bird LLP is an Equal Opportunity Employer does not discriminate on the bases of any status protected under federal, state, or local law. Applicants will be considered regardless of their sex, race, age, religion, color, national origin, ancestry, physical disability, mental disability, medical condition (associated with cancer, a history of cancer, or genetic characteristics), HIV/AIDS status, genetic information, marital status, sexual orientation, gender, gender identity, gender expression, military and veteran status, or other protected category under the law on the basis of race, color, religion, sex, age, sexual orientation, gender identity and/or expression, national origin, veteran status or disability in relation to our recruiting, hiring, and promoting practices.
The statements contained in this position description are not necessarily all-inclusive, additional duties and responsibilities may be assigned, and requirements may vary from time to time.
Professional business references and a background screening will be required for all final applicants selected for a position.
If you need assistance or an accommodation due to a disability you may contact donavan.mclean@alston.com.

This listing is sourced directly from Alston's careers page and normalized into a canonical job model.