Senior Regulatory Affairs Program Lead

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Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Product Submissions and Registration
Job Category:
Professional
All Job Posting Locations:
Galway, Ireland
Job Description:
We are searching for the best talent as Senior Regulatory Affairs Program Lead to be in Galway, Ireland.
Purpose of the role:
The Senior Regulatory Affairs Program Lead 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 and ongoing regulatory compliance.
What you will be doing?
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).
Clearly defines and prioritises decision criteria, considers the benefits and risks of each solution before making decisions.
Considers all of the available facts when situations are ambiguous in order to make the best possible decision.
Develops labelling specifications and approves proposed labelling and packaging, after evaluating conformance to regulations is required.
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
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.
What you will bring:
Strong experience in the medical device industry, with some experience 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 / BSI
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.
Required experience:
Knowledge/working experience of the European Medical Device Directive/Regulation (EU MDD 93/42/EEC and EU MDR 2017/745), FDA's 21 CFR Part 812 (Investigational Device Exemption), 21 CFR Part 807 (Premarket Notifications), 21 CFR Part 814 (Premarket Approval), and relevant European and US regulations and standards, including Quality System requirements, such as 21 CFR Part 820 (Quality System Regulation), EN ISO 13485, etc.
Knowledge of other applicable medical device regulations, e.g. Brazilian, Canadian, Australian, Japanese, Korean, etc., advantageous.
Excellent interpersonal skills and ability to work with people to achieve results.
Excellent written and communication skills, fluency in English.
Good judgment/decision making and problem-solving ability, capable of understanding the impact of decision making on both Cerenovus and their customers.
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