Regulatory Affairs Specialist

Sunrise Systems Inc

🇺🇸 United States
On-site
1 day ago

Regulatory Compliance
ACA

1 day ago

Not enough detail in this posting to match

Our client, a leading Medical Device manufacturing company, is looking for a Regulatory Affairs Specialist. This is for an initial duration of 12 months and is located at Chaska, MN.

Job Title: Regulatory Affairs Specialist
Reference ID:26-05136
Location: Chaska, MN
Duration: 12 months
Job Type: Contract (Candidates must be able to work on W2 without VISA sponsorship)

Description:

The Senior Regulatory Affairs Specialist plans, coordinates, facilitates, and reports on Client 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.

Compensation: The hourly rate for this position is between $50-54 per hour.

Factors which may affect starting pay within this range may include [geography/market, skills, education, experience and other qualifications of the successful candidate].

Benefits: Sunrise offers ACA compliant medical coverage/dental insurance/vision insurance to all employees. We also offer Sick time benefits as required per State regulations.

Interested and Qualified candidates, please send your most recently updated word document resume toJaffer.s@sunrisesys.com orPavan.P@sunrisesys.com

Regulatory Affairs Specialist · Sunrise Systems Inc

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