Regulatory Affairs Associate
Company: Nesco Resource
Posted on: April 9, 2021
Summary: The primary responsibility is to support the day-to-day
Regulatory Affairs base business operations within both Clinical
Laboratories and Transfusion Medicine . The RA Associate, with
oversight, will also manage and oversee the coordination,
compilation and submission of documentation in support of
regulatory applications to health authorities. This position will
have significant regular interactions with Regulatory staff located
globally. This position is in either Pencoed, Wales, UK; Raritan,
NJ; or Rochester NY. Responsibilities:
- Support base business activities, such as responding to
International Regulatory requests via the IRRT tool.
- Drafting and managing Change notifications to International
Regulatory colleagues in support of developing regulatory
registration impact assessments associated with product
- Support regulatory colleagues to prepare their submissions by
performing tasks such as completing Regulatory forms, letters of
Explanation, and submssions for Apostille and Legalization as well
as editorial reviews of submission content.
- With oversight, provide regulatory support to Clin Labs and
Transfusion Medicine project teams in terms of submission
requirements, timing, and risks.
- Interact with US and/or International regulatory personnel to
define submission content, expedite pending applications, and
resolve regulatory matters.
- Prepare submissions to meet regulatory agency
- Identify and/or support process improvement projects to
streamline current activities and increase department
- Maintain tracking systems to reflect updated information
associated with work content.
- Maintain evidence of adequate training for the role.
- Perform other work-related duties, as assigned. Qualifications:
- A minimum of a Bachelor's degree in a scientific or related
discipline is required.
- Minimum 3-5 years of experience in a regulated Medical Device
or Pharmaceuticals Industry required, IVD Industry experience
- A minimum of 2 years of experience developing and executing
Regulatory strategies in support of Market Products and Product
Development for Medical Devices is preferred, In Vitro Diagnostic
experience is preferred.
- Excellent interpersonal, teamwork and verbal/written
communication skills are required.
- Good organizational skills and an ability to manage multiple
- The ability to demonstrate model behavior, understand
priorities and encourage others to drive for results will be
- Ability to cross-train with peers.
- The ability to work with business partners across geographies
and time zones is critical. Key Working Relationships: Must
maintain excellent working relationships with Domestic and
International Regulatory Affairs colleagues, R&D, Operations,
Global Publications, Regional QRA partners and Business Managers
located in the Regions, i.e. ASPAC, EMEA, China, LAR and quality /
Nesco Resource and affiliates (Lehigh G.I.T Inc, and Callos
Resource, LLC) is an equal employment opportunity employer and does
not discriminate on the basis of race, color, religion, sex, sexual
orientation, gender identity, national origin, disability, age, or
veteran status, or any other legally protected characteristics with
respect to employment opportunities.
Keywords: Nesco Resource, Trenton , Regulatory Affairs Associate, Other , Raritan, New Jersey
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