Abel Solutions→
Engineer and Regulatory Specialist… at Abel Solutions · Colorado…
Skills
Job Description
Applied Technical Services, LLC, is a leading provider of critical testing, inspection, certification, and compliance services. The company serves clients across a diverse set of large and stable end markets including manufacturing, power generation, aerospace, medical, and defense. ATS was founded in 1967 and is headquartered in Marietta, GA. Today the Company employs nearly 2,100 team members in over 95 locations across the United States
Position Summary: The Engineer and Regulatory Specialist is responsible for preparing, reviewing, and submitting technical documentation for FDA submission as well as providing regulatory and technical consulting services to clients.
POSITION DUTIES & RESPONSIBILITIES:
Prepare, compile, review, and submit technical documentation for FDA regulatory submissions.
Support responses to FDA requests for additional information and assist in resolving regulatory questions throughout the submission review process.
Monitor changes in FDA regulations, guidance documents, and industry standards to ensure regulatory submission remain current and compliant.
Create technical protocols with research-based acceptance criteria for mechanical testing
Perform literature reviews by searching, reviewing, and summarizing documents, as required for memos such as acceptance criteria for validation activities.
Advise clients on regulatory pathways, submission strategies, technical documentation requirements, and regulatory risks.
Participate in client meetings, technical discussions, and project reviews to communicate regulatory expectations, project progress and potential compliance issues.
Research and write engineering justification memos on various topics
Manage multiple multi-disciplinary projects related to the above.
PROFESSIONAL EXPERIENCE REQUIREMENTS:
- Fluent in Microsoft Word and Excel, as well as technical journal database searching.
- Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents.
- Recommended: 1-3 years compliance experience in a FDA regulated company
- Demonstrated expertise in effective writing skills.
- Position requires visual capability of reading, regulations, and documents, etc. Mental effort and verbal skills required to effectively relate potential problems to appropriate personnel; requires continuous attention to detail while performing job requirements.
EDUCATION, TRAINING, AND SKILL REQUIREMENTS:
- Bachelor’s degree (B.S.) in engineering
- 1-5 years’ experience in engineering technical position
- Regulatory affairs training (e.g. RAPS),
- Outstanding written and verbal skills.
- The ability to work with peers across functions/departments.
- Significant attention to details. Knowledge of FDA regulations as they relate to medical devices.
- Proven experience in managing several projects simultaneously. Must be able to multitask and prioritize multiple endeavors, define problems, collect data, establish facts and draw valid conclusions.
- Must be a self-starter, flexible and adaptable.
ITAR
U.S. Persons Only: A requirement of this position is access to information that is subject to U.S. export controls under the U.S. International Traffic in Arms Regulations (ITAR). Accordingly, the company will consider only U.S. Persons for this position. A U.S. Person includes (a) U.S. citizens or nationals; (b) U.S. lawful permanent residents (i.e., green card holders); (c) persons granted refugee status; or (d) persons granted asylum in the United States. This information is collected solely for purposes of complying with U.S. export control requirements and will not be used to unlawfully discriminate in the hiring process.
EOE/AA/M/F/Vet/Disability
Applied Technical Services is an equal opportunity employer where employment is based upon personal capabilities and qualifications without discrimination due to race, color, religion, gender, age, national origin, disability, veteran status or any other protected characteristic as established by law.