Regulatory Affairs Manager (100% Remote)
Posted on :
30-06-2022
Employer Active
1 Vacancy
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Job Description
Req ID : 1176712
Our client, a world leader in Pharmaceuticals and In-Vitro Diagnostics (IVD) tools is looking for Regulatory Affairs Manager (100% Remote) .
Job Title : Regulatory Affairs Manager (100% Remote)
Job Duration : 2 years long Contract (Possibility Of Extension/Fullltime Conversion)
Job Location: Indianapolis, IN
- Primarily responsible for directly receiving, tracking and fulfilling international Regulatory affiliate (clients personnel that have direct contact with their respective health authorities) questions/requests pertaining to product registrations, license renewals, product changes, and annual registrations from International Market.
- Manages the development and implementation of Regulatory strategies and plans to support the timely introduction of new products and the preparation and review of international regulatory submissions to achieve timely and cost-effective approvals
- Interacts internally across multiple functional areas/sites and externally with international Regulatory affiliates to facilitate the registration of clients products (CDx).
- Manages regulatory responsibilities associated with the development, support, and manufacturing of the Company s medical device products (including compliance, and MDSAP Audit support).
- Works on diverse problems requiring significant analysis and evaluation of intangible variables; may refer to established precedents and policies.
- May provides coaching, training, and opportunities to develop skills, and gives ongoing, constructive, and timely feedback on performance and progress toward goals and expectations.
- Strong organizational skills and attention to detail are required.
- Ability to work in a fast-paced/entrepreneurial environment.
- Ability to work in a cross-functional, highly interdependent team structure
- Results and goal-oriented.
- A high degree of initiative with the ability to work independently.
- Excellent oral and written communication skills.
- Ability to prepare and present information to groups.
- Ability to comprehend principles of engineering, physiology, and medical device use.
- Ability to plan and organize work while remaining flexible.
- Regulatory Affairs experience
"regulatory affairs" "regulatory documentation" "CDx" registrations
Employment Type
Full Time
Key Skills
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