Engineer and Regulatory Specialist

Applied-Technical-Services-LL; Colorado Springs (CO); In loco; USD 75.000 - 110.000; Tempo pieno

Descrizione del lavoro

Applied Technical Services, LLC seeks an Engineer and Regulatory Specialist to prepare, review, and submit FDA regulatory documentation for medical device submissions. You will support information requests, monitor regulatory changes, and craft protocols and memos to ensure compliance.

You will advise clients on regulatory pathways, participate in technical discussions, and manage multiple multidisciplinary projects while maintaining meticulous attention to detail and strong communication skills.

Competenze

• Bachelor’s degree in engineering or related field.
• Knowledge of FDA regulations and regulatory submissions for medical devices.
• Strong written and verbal communication skills; ability to manage multiple projects.

Mansioni

• Prepare, review, and submit FDA regulatory documentation for submissions.
• Support FDA requests for information and resolve regulatory questions.
• Monitor FDA regulations and industry standards to keep submissions compliant.
• Create technical protocols and literature reviews for validation activities.
• Advise clients on regulatory pathways and submission strategies.
• Participate in client meetings and project reviews to communicate regulatory expectations.

Conoscenze

Regulatory writing

FDA regulations

Project management

Attention to detail

Communication skills

Formazione

Bachelor's degree in engineering

Strumenti

Microsoft Word

Microsoft Excel

Literature databases

Descrizione del lavoro

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 StatesPosition 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 testingPerform 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 topicsManage 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 companyDemonstrated 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 engineering1-5 years’ experience in engineering technical positionRegulatory 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.ITARU.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/DisabilityApplied 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.