Our client, a medical device company in Galway is currently looking to recruit a Senior Regulatory Affairs Specialist for their site.
The Regulatory Affairs Specialist provides independent regulatory guidance to product development teams on International pre-marketing applications, and any related submissions to support optimal timelines for new/modified product launches.
- Guides conformance with applicable regulations in product development, support of claims, content labelling, and promotional materials. The role assists in the development of best practices for Regulatory Affairs processes.
- Helps define data and information needed for regulatory approvals in conjunction with cross-functional product development teams.
- Leverages a deep scientific and technical understanding of regulated products under scope of responsibility to provide strategic guidance and support for product development and life-cycle management of products (e.g. represents Regulatory in the complaint handling and field action process).
- Manages the local site transition to the New Medical Device Regulation and supports the integration in the J&J regulatory organisation.
- Develops labelling specifications and approves proposed labelling and packaging, after evaluating conformance to regulations is required
- Ensures compliance with regulatory agency regulations and interpretations.
- Prepares responses to regulatory agencies' questions and other correspondence.
- Provides regulatory advice to project teams.
- Guides conformance with applicable regulations in product development, support of claims and label content
- Defines data and information needed for regulatory approvals. Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
- Assist in the development of product reimbursement strategies. Lead applications for product reimbursements in line with company strategies
- Provides Regulatory Affairs support during internal and external audits
- Represents Regulatory Affairs on cross-functional project teams
Essential Skills / Experience
- Minimum education of degree in a technical field.
- Minimum 6 years’ experience in the medical device industry, with at least 3 years in a position in regulatory affairs or related/equivalent field.
- Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience the regulatory or quality function.
- Experience of inspection by an external agency, such as the FDA.
- Ability to work well under deadlines and pressure
- Demonstrated track record in
- Submission of licenses and authorizations for the maintenance of existing products
- International registrations and dossiers
- Execution of regulatory strategies that align with business deliverables
For further information on this Senior Regulatory Affairs Specialist role in Galway please contact Bimi Felix on 086 8395533 / firstname.lastname@example.org
Check out all our open jobs on our HERO Recruitment website – www.hero.ie
Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.