PT
Senior Regulatory Affairs Specialist
Primary Talent Partners
- 🇺🇸 United States
- On-site
- Senior
- 17 hours ago
- $47 – $52 / hour
- ACA
- Regulatory Compliance
17 hours ago
Not enough detail in this posting to match
Pay:$47.00 - $52.00/hr; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment. Candidates must be legally authorized to work in the United States and must be able to sit on Primary Talent Partners W2 without sponsorship.
Description:
The Senior Regulatory Affairs Specialist plans, coordinates, facilitates, and reports on Beckman Coulter regulatory programs. The incumbent's primary responsibilities will be the evaluation, coordination, preparation and implementation of post-market Regulatory Affairs activities.
Responsibilities may include:
- Administration of the company's complaint management program for compliance to corporate requirements
- Planning and implementing pre-market registration, reporting and compliance activities in accordance with the development center business plans.
- Implementing global regulatory compliance programs for product corrective action and/or adverse event reporting.
- Preparing premarket or other regulatory submissions (510(k), PMA, Technical Dossiers, etc.) for US and other governments.
- Additionally, may provide assistance to technical departments, manufacturing business centers and suppliers in the creation and structuring of clinical data for pre-market notifications.
- Functioning as a team expert for promotional materials review, experimental designs, data analysis and product labeling as they relate to registration and commercialization of medical devices.
Educational requirements:
- Bachelor's degree in field with 5+ years exp. OR Master's degree in field with3+ years exp.
- Medical Technologist background and IVD experience strongly desired.
Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com
#PTPJobs
#LI-PTP
Senior Regulatory Affairs Specialist · Primary Talent Partners