Johnson & Johnson
Senior Regulatory Affairs Specialist - Cerenovus (Hybrid role) - Galway, Ireland
Senior Regulatory Affairs Specialist - Hybrid role
3 days on site at Cerenovus in Galway, Ireland plus 2 days remote working
12 month contract to start ASAP
CERENOVUS, part of Johnson & Johnson Medical Devices Companies, is a global leader in neurovascular care.
Our commitment to changing the trajectory of stroke is inspired by our long heritage and dedication to helping physicians protect people from a lifetime of hardship.
CERENOVUS offers a broad portfolio of devices used in the endovascular treatment of haemorrhagic and ischemic stroke.
The Senior 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 and ongoing regulatory compliance.
Duties and Responsibilities:
• 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
• 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.
• 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
• 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.
Experience and Education Required:
Minimum 3 years' experience in the medical device industry, with at least 2 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.
Required Knowledge and Skills:
• 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.
• Motivated and an enthusiastic self-starter with the ability to work under own initiative and as a team
In return for this role you will receive a very competitive hourly rate. A minimum 12 month contract & an opportunity to work with a Global Leader within the Pharmaceutical sector, Johnson & Johnson.
Things to remember before applying for this role:
- We are looking to process the first round of applications within the next 2 working days.
- We do not accept applications via email.
If you are interested in this role please apply now!
Make sure you fill out your application in full, your personal CV will be used for the recruiter’s reference only, they are not sent to Hiring Managers.
Ensure all relevant information is included in your application!
Thank you very much and we look forward to receiving your application.
If you would like some additional information about the role please contact: Trish.Delaney@randstadsourceright.co.uk
Diversity, Equity & Inclusion:
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences
That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.