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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?
1. Help define data and information needed for regulatory approvals in conjunction with cross-functional product development teams.
2. Leverage a deep scientific and technical understanding of regulated products to provide strategic guidance and support for product development and lifecycle management, including representing Regulatory in complaint handling and field actions.
3. Define and prioritize decision criteria, considering benefits and risks before making decisions, especially in ambiguous situations.
4. Develop labeling specifications and approve proposed labeling and packaging, ensuring conformance to regulations.
5. Guide conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.
6. Ensure compliance with regulatory agency regulations and interpretations.
7. Prepare responses to regulatory agencies' questions and other correspondence.
8. Provide regulatory advice to project teams.
9. Gather and assemble information necessary for submissions in accordance with regulations and guidelines.
10. Assist in developing product reimbursement strategies and lead applications for reimbursements aligned with company strategies.
11. Support Regulatory Affairs during internal and external audits.
12. Represent Regulatory Affairs on cross-functional project teams.
What you will bring:
1. Strong experience in the medical device industry, with experience in regulatory affairs or related fields.
2. Ability to communicate clearly and effectively to diverse audiences.
3. Experience with inspections by external agencies like the FDA / BSI.
4. Ability to work well under deadlines and pressure.
5. Proven track record in licensing, international registrations, and regulatory strategies.
Required experience:
* Knowledge of European and US medical device regulations (EU MDD, EU MDR, FDA regulations, etc.) and quality system requirements.
* Knowledge of regulations in other countries (Brazil, Canada, Australia, Japan, Korea) is advantageous.
* Excellent interpersonal and communication skills, fluency in English.
* Good judgment, decision-making, and problem-solving skills, understanding the impact of decisions on the company and customers.
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