Associate Domain Architect- Market Clearance

Associate Domain Architect Market Clearance

Professional & Solution Services US Cambridge, MA

In this position, you will make transformative and innovative contributions to global regulatory affairs and quality systems operations for medtech industry customers worldwide. This is a full-time position that reports to the Vice President, Solution Services.

Position responsibilities also include:

• Lead and perform professional services and solutions development duties in global RA/QA and related systems development, including supervisory responsibilities for analyst and development functions.
• Demonstrate a mature, professional attitude and responsive, high-quality teamwork.
• Achieve all requisite core and professional competencies, demonstrating subject mastery on core certifications (Microsoft MOS and MTA, foreign language, and typing) and professional certifications (RAPS RAC (US, EU, and Global), and ASQ CQPA and CBA).
• Ongoing professional development and job performance sufficient to qualify for the position of Solution Architect within 12 months of employment.
• Minimum 5 years successful medtech industry experience.
• Undergraduate BS or equivalent degree in electrical, chemical, or mechanical engineering.
• Graduate JD or equivalent degree in law from a leading US law school.
• Must possess an active license to practice law.
• Most possess or be eligible to sit for a foreign language competency certification in one of the following: German; Korean; Japanese; or Chinese.
• Must be able to demonstrate a strong working knowledge of applicable medtech Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Clinical Practices (GCP), regulations, standards, and product development processes.
• Must possess or be eligible to sit for Regulatory Affairs Professional Society (RAPS) and American Society for Quality (ASQ) certification credentials.
• Certifications in RA, QA, and/or Microsoft information technology a plus
• Excellent communication (both oral and written) skills
• Excellent teamwork, time management, planning, and organizing skills
• Must be flexible and willing to work hours as needed to meet deadlines and goals.

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  • Clinivation is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, sexual orientation, gender identity or expression, religion, national origin, marital status, age, disability, veteran status, genetic information, or any other protected status.

    Clinivation does not accept employment applications or resumes from third-parties. Clinivation defines an employment applicant as person who indicates interest in a specific open position, follows our procedure that requires submitting a employment application or resume directly to the clinivation human resources authority, and indicates possession of the advertised or established qualifications for the position.

    All unsolicited employment applications or resumes from agencies will be considered direct applicants, and no referral fees for such will be paid.

    Clinivation solutions deliver the digital advantage to outperform in new business environments with innovative and better ways to succeed in global development and commercialization.

    Our cross-functional software brings people and knowledge to the point of action to eliminate revenue traps, overcome process complexity, and enable execution with full visibility, decision support, and controls.

    Trusted for millions of products by hundreds of companies worldwide, our modular, interoperating applications yield new, scalable operating models that directly
    connect biomedical innovation with high-value inflection points and business growth.

    The worlds leading medtech, pharmaceutical, and biotech organizations partner with clinivation because of our industry expertise and our transformative solutions
    that seamlessly integrate existing business processes and enterprise infrastructure- leveraging cloud, hybrid, and on-premises architectures.

    Our vision is to inspire our shared purpose of bringing innovation to life with the value of information technology.

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