Johnson & Johnson
Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist
Location: Cerenovus, Galway
Hybrid working - Working 3 days on site and 2 days remote
ASAP start - 18 month contract.
Hourly Pay Rates: €32 - €35 PAYE
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 & 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 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).
- 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 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.
Education & experience 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 licences and authorizations for the maintenance of existing products − International registrations and dossiers
- Execution of regulatory strategies that align with business deliverables.
Required knowledge, Skills, Abilities, Certifications/ Licences & Affiliations
- 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 judgement/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 player.
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 via the link below
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!
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 in Ireland 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”.