Associate Domain Architect- Market Clearance
Company: CLINIVATION, INC.
Posted on: May 3, 2021
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
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
- Demonstrate a mature, professional attitude and responsive,
- 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
- Ongoing professional development and job performance sufficient
to qualify for the position of Solution Architect within 12 months
- 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
- 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)
- 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
- Must be flexible and willing to work hours as needed to meet
deadlines and goals.
APPLY FOR THIS POSITION
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- Upload Your Resume Accepted file types: doc, docx, pdf.
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
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
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
Our vision is to inspire our shared purpose of bringing
innovation to life with the value of information technology.
Keywords: CLINIVATION, INC., Cambridge , Associate Domain Architect- Market Clearance, Other , cambridge, Massachusetts
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