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.
Position qualifications include:
- 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.
APPLY FOR THIS POSITION
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.