Direct message the job poster from Randstad Life Sciences US
Charulatha Vedhachalam-Felse
Scientist | Executive Recruiter _ RLS at Randstad Life Sciences
A global medical device company continuously innovated with new products and technologies that revolutionize treatments for doctors and their patients.
The Regulatory Affairs Specialist will assist or lead a variety of regulatory tasks in support of global regulatory strategy, regulatory assessment for modified product, regulatory filing for new/modified product, regulatory operation and processes, post-market surveillance. This role requires strong organization, written and oral communication skills, and must be able to perform tasks with accuracy and a high attention to detail.
In this role, you will...
Perform regulatory assessments for product changes including regulatory reportability decisions
Work with cross functional team and international regulatory colleagues to develop and implement global regulatory strategy to support business global expansions
Support regulatory filing like a 510(k) or Pre-submission or a new/amended Health Canada License application for a Class II new product and may include renewal of Licenses
Support international regulatory filing
Assist in streamlining or updating regulatory processes
Assist in regulatory intelligence activities
Assist in post-market surveillance activities, such as complaint handling and vigilance reporting
Assist in regulatory involved QMS activities, such as CAPA, Non-Conformance
Perform other related assignments as required
In this role, you’ll need ...
Bachelor’s degree in Science, Engineering, Regulatory, a medical field, or an equivalent educational background with a focus on technical writing, scientific methodologies, and problem-solving.
Must be available to work with a hybrid schedule (3 days in office, 2 days remote) in office:
1-2 years experience in medical device industry. Experience of medical device, SaMD development, or regulatory affairs is preferred
Knowledge of US regulation in medical device is required
In-depth knowledge and skills with computer applications and business tools such as e-mail, MS Word, Excel, PowerPoint
Motivated and quick to learn new concepts and understand technical writing and medical device regulations
Proficient written and oral communication skills
Organized and detail-oriented
Ability to manage work effectively in a remote capacity in a fast-paced, dynamic but often ambiguous workplace
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Research
Industries
Medical Equipment Manufacturing and Biotechnology Research
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