Reg Affairs Manager

On-site
- Limerick, Ireland
Regulatory Affairs

Job description

Pale Blue Dot® Recruitment – Ireland’s go-to STEM talent partner – is recruiting on behalf of an innovative IVD manufacturer seeking a Regulatory Manager to lead their regulatory function and ensure ongoing compliance across global markets.

This is a senior-level opportunity for an experienced regulatory professional who thrives in a fast-paced, quality-driven environment. Reporting to the Chief Operations Officer, you will lead a high-performing regulatory team and manage global compliance strategies to support the company’s current and future product portfolio.

Key Responsibilities incluce but are not limited to:

Lead, coach, and develop a team of regulatory professionals to deliver results.
Oversee implementation of regulatory strategies in line with evolving requirements.
Manage and maintain technical documentation for Class A and B IVD products.
Drive post-market surveillance and risk management processes.
Coordinate vigilance reporting for CE-IVD and other international markets.
Maintain and expand regulatory certifications in existing and new territories.
Collaborate cross-functionally with R&D, Manufacturing, and Quality on compliance and product strategies.
Stay current on international regulatory requirements (EU IVDR, MDR, etc.) and communicate implications company-wide.
Act as Deputy Person Responsible for Regulatory Compliance (PRRC), when needed.

Job requirements

BSc in Molecular Biology or related scientific discipline.
Minimum 5 years' regulatory experience within the Medical Device or IVD sector.
At least 2 years' experience leading or supervising regulatory personnel.
Expert knowledge of ISO 13485 and EU IVDR/MDR.
Strong documentation, organisational and interpersonal skills.
Ability to manage multiple projects and competing priorities with precision.

Desirable:

Experience with Software as a Medical Device (SaMD) and associated standards.
Proven experience liaising with Notified Bodies or international Regulatory Authorities.

This is a rare opportunity to join a dynamic, forward-thinking company at the forefront of diagnostic innovation. If you're a proactive leader ready to make an impact, apply now.

🧬 Pale Blue Dot® Recruitment – Experts in STEM Workforce Solutions

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Candidate Genuine Expression of Interest Statement : “I hereby declare my genuine expression of interest in this vacancy and any other opportunity that Pale Blue Dot Recruitment provides me and I have no intention of using this process as means of self interest with my current employer (i.e. to obtain a pay rise and / or a promotion)"

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As part of your application, you have an option to be part of our talent pool. By being part of our talent pool you may be contacted by someone in Pale Blue Dot Recruitment in relation to similar roles or opportunities that we feel may be of interest to you. Your details will be maintained as part of our privacy policy found on this website and our company website (https://pbdrecruit.ie/privacy-policy/) and (https://pbdrecruit.ie/terms-of-service-for-candidates/). Do you wish to be part of our talent pool?

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You acknowledge that Pale Blue Dot Recruitment will represent you for this vacancy or any other vacancy our Client deems you suitable for?

Yes

An employer can decide whether to sponsor an employment visa for a successful candidate. Do you require sponsorship to work in Ireland?

Yes

Legal Agreements

Privacy Policy incorporating GDPR and Disclaimers
Effective date: August 21, 2018
Pale Blue Dot Recruitment Limited (“us”, “we”, or “our”) operates the https://www.pbdrecruit.ie website (hereinafter referred to as the “Service”).
This page informs you of our policies regarding the collection, use and disclosure of personal data when you use our Service and the choices you have associated with that data.
We use your data to provide and improve the Service. By using the Service, you agree to the collection and use of information in accordance with this policy. Unless otherwise defined in this Privacy Policy, the terms used in this Privacy Policy have the same meanings as in our Terms and Conditions, accessible from https://www.pbdrecruit.ie
Definitions
Service
Service is the https://www.pbdrecruit.ie website operated by Pale Blue Dot Recruitment Limited
Personal Data
Personal Data means data about a living individual who can be identified from those data (or from those and other information either in our possession or likely to come into our possession).
Usage Data
Usage Data is data collected automatically either generated by the use of the Service or from the Service infrastructure itself (for example, the duration of a page visit).
Cookies
Cookies are small files stored on your device (computer or mobile device).
Data Controller
Data Controller means the natural or legal person who (either alone or jointly or in common with other persons) determines the purposes for which and the manner in which any personal information are, or are to be, processed.
For the purpose of this Privacy Policy, we are a Data Controller of your Personal Data.
Data Processors (or Service Providers)
Data Processor (or Service Provider) means any natural or legal person who processes the data on behalf of the Data Controller.
We may use the services of various Service Providers in order to process your data more effectively.
Data Subject (or User)
Data Subject is any living individual who is using our Service and is the subject of Personal Data.
Information Collection and Use
We collect several different types of information for various purposes to provide and improve our Service to you.
Types of Data Collected
Personal Data
While using our Service, we may ask you to provide us with certain personally identifiable information that can be used to contact or identify you (“Personal Data”). Personally identifiable information may include, but is not limited to:
Email address
First name and last name
Phone number
Address, State, Province, ZIP/Postal code, City
Cookies and Usage Data
We may use your Personal Data to contact you with newsletters, marketing or promotional materials and other information that may be of interest to you. You may opt out of receiving any, or all, of these communications from us by following the unsubscribe link or instructions provided in any email we send or by contacting us.
Usage Data
We may also collect information on how the Service is accessed and used (“Usage Data”). This Usage Data may include information such as your computer’s Internet Protocol address (e.g. IP address), browser type, browser version, the pages of our Service that you visit, the time and date of your visit, the time spent on those pages, unique device identifiers and other diagnostic data.
Tracking & Cookies Data
We use cookies and similar tracking technologies to track the activity on our Service and we hold certain information.
Cookies are files with a small amount of data which may include an anonymous unique identifier. Cookies are sent to your browser from a website and stored on your device. Other tracking technologies are also used such as beacons, tags and scripts to collect and track information and to improve and analyse our Service.
You can instruct your browser to refuse all cookies or to indicate when a cookie is being sent. However, if you do not accept cookies, you may not be able to use some portions of our Service.
Examples of Cookies we use:
Session Cookies.We use Session Cookies to operate our Service.
Preference Cookies.We use Preference Cookies to remember your preferences and various settings.
Security Cookies.We use Security Cookies for security purposes.
Use of Data
Pale Blue Dot Recruitment Limited uses the collected data for various purposes:
To provide and maintain our Service
To notify you about changes to our Service
To allow you to participate in interactive features of our Service when you choose to do so
To provide customer support
To gather analysis or valuable information so that we can improve our Service
To monitor the usage of our Service
To detect, prevent and address technical issues
To provide you with news, special offers and general information about other goods, services and events which we offer that are similar to those that you have already purchased or enquired about unless you have opted not to receive such information
Legal Basis for Processing Personal Data under the General Data Protection Regulation (GDPR)
If you are from the European Economic Area (EEA), Pale Blue Dot Recruitment Limited legal basis for collecting and using the personal information described in this Privacy Policy depends on the Personal Data we collect and the specific context in which we collect it.
Pale Blue Dot Recruitment Limited may process your Personal Data because:
We need to perform a contract with you
You have given us permission to do so
The processing is in our legitimate interests and it is not overridden by your rights
To comply with the law
Retention of Data
Pale Blue Dot Recruitment Limited will retain your Personal Data only for as long as is necessary for the purposes set out in this Privacy Policy. We will retain and use your Personal Data to the extent necessary to comply with our legal obligations (for example, if we are required to retain your data to comply with applicable laws), resolve disputes and enforce our legal agreements and policies.
Pale Blue Dot Recruitment Limited will also retain Usage Data for internal analysis purposes. Usage Data is generally retained for a shorter period of time, except when this data is used to strengthen the security or to improve the functionality of our Service, or we are legally obligated to retain this data for longer periods.
Transfer of Data
Your information, including Personal Data, may be transferred to — and maintained on — computers located outside of your state, province, country or other governmental jurisdiction where the data protection laws may differ from those of your jurisdiction.
If you are located outside Ireland and choose to provide information to us, please note that we transfer the data, including Personal Data, to Ireland and process it there.
Your consent to this Privacy Policy followed by your submission of such information represents your agreement to that transfer.
Pale Blue Dot Recruitment Limited will take all the steps reasonably necessary to ensure that your data is treated securely and in accordance with this Privacy Policy and no transfer of your Personal Data will take place to an organisation or a country unless there are adequate controls in place including the security of your data and other personal information.
Disclosure of Data
Business Transaction
If Pale Blue Dot Recruitment Limited is involved in a merger, acquisition or asset sale, your Personal Data may be transferred. We will provide notice before your Personal Data is transferred and becomes subject to a different Privacy Policy.
Disclosure for Law Enforcement
Under certain circumstances, Pale Blue Dot Recruitment Limited may be required to disclose your Personal Data if required to do so by law or in response to valid requests by public authorities (e.g. a court or a government agency).
Legal Requirements
Pale Blue Dot Recruitment Limited may disclose your Personal Data in the good faith belief that such action is necessary to:
To comply with a legal obligation
To protect and defend the rights or property of Pale Blue Dot Recruitment Limited
To prevent or investigate possible wrongdoing in connection with the Service
To protect the personal safety of users of the Service or the public
To protect against legal liability
Security of Data
The security of your data is important to us but remember that no method of transmission over the Internet or method of electronic storage is 100% secure. While we strive to use commercially acceptable means to protect your Personal Data, we cannot guarantee its absolute security.
Our Policy on “Do Not Track” Signals under the California Online Protection Act (CalOPPA)
We do not support Do Not Track (“DNT”). Do Not Track is a preference you can set in your web browser to inform websites that you do not want to be tracked.
You can enable or disable Do Not Track by visiting the Preferences or Settings page of your web browser.
Your Data Protection Rights under the General Data Protection Regulation (GDPR)
If you are a resident of the European Economic Area (EEA), you have certain data protection rights. Pale Blue Dot Recruitment Limited aims to take reasonable steps to allow you to correct, amend, delete or limit the use of your Personal Data.
If you wish to be informed about what Personal Data we hold about you and if you want it to be removed from our systems, please contact us.
In certain circumstances, you have the following data protection rights:
The right to access, update or delete the information we have on you.Whenever made possible, you can access, update or request deletion of your Personal Data directly within your account settings section. If you are unable to perform these actions yourself, please contact us to assist you.
The right of rectification.You have the right to have your information rectified if that information is inaccurate or incomplete.
The right to object.You have the right to object to our processing of your Personal Data.
The right of restriction.You have the right to request that we restrict the processing of your personal information.
The right to data portability.You have the right to be provided with a copy of the information we have on you in a structured, machine-readable and commonly used format.
The right to withdraw consent.You also have the right to withdraw your consent at any time where Pale Blue Dot Recruitment Limited relied on your consent to process your personal information.
Please note that we may ask you to verify your identity before responding to such requests.
You have the right to complain to a Data Protection Authority about our collection and use of your Personal Data. For more information, please contact your local data protection authority in the European Economic Area (EEA).
Service Providers
We may employ third party companies and individuals to facilitate our Service (“Service Providers”), provide the Service on our behalf, perform Service-related services or assist us in analysing how our Service is used.
These third parties have access to your Personal Data only to perform these tasks on our behalf and are obligated not to disclose or use it for any other purpose.
Links to Other Sites
Our Service may contain links to other sites that are not operated by us. If you click a third party link, you will be directed to that third party’s site. We strongly advise you to review the Privacy Policy of every site you visit.
We have no control over and assume no responsibility for the content, privacy policies or practices of any third party sites or services.
Children’s Privacy
Our Service does not address anyone under the age of 18 (“Children”).
We do not knowingly collect personally identifiable information from anyone under the age of 18. If you are a parent or guardian and you are aware that your Child has provided us with Personal Data, please contact us. If we become aware that we have collected Personal Data from children without verification of parental consent, we take steps to remove that information from our servers.
Changes to This Privacy Policy
We may update our Privacy Policy from time to time. We will notify you of any changes by posting the new Privacy Policy on this page.
We will let you know via email and/or a prominent notice on our Service, prior to the change becoming effective and update the “effective date” at the top of this Privacy Policy.
You are advised to review this Privacy Policy periodically for any changes. Changes to this Privacy Policy are effective when they are posted on this page.
Contact Us
If you have any questions about this Privacy Policy, please contact us:
By email: info@pbdrecruit.ie
DISCLAIMERS
Last updated: 11/09/2018
The information contained on https://www.pbdrecruit.ie website (the "Service") is for general information purposes only. Pale Blue Dot Recruitment Limited assumes no responsibility for errors or omissions in the contents on the Service. In no event shall Pale Blue Dot Recruitment Limited be liable for any special, direct, indirect, consequential, or incidental damages or any damages whatsoever, whether in an action of contract, negligence or other tort, arising out of or in connection with the use of the Service or the contents of the Service. Pale Blue Dot Recruitment Limited reserves the right to make additions, deletions, or modification to the contents on the Service at any time without prior notice. Pale Blue Dot Recruitment Limited does not warrant that the website is free of viruses or other harmful components.
External links disclaimer
Pale Blue Dot Recruitment Limited website may contain links to external websites that are not provided or maintained by or in any way affiliated with Pale Blue Dot Recruitment Limited . Please note that Pale Blue Dot Recruitment Limited does not guarantee the accuracy, relevance, timeliness, or completeness of any information on these external websites.
Recruitment Disclaimer
Pale Blue Dot Recruitment makes no representations as to the availability of positions advertised on the https://www.pbdrecruit.ie website and does not guarantee that any client will offer any candidate an interview or respond to the candidates submission of the information.
These disclaimers apply to third party sites used by Pale Blue Dot Recruitment Limited for the process of the services provided.
All candidates acknowledge and abide by these terms and the terms of Service for Candidates found here https://pbdrecruit.ie/terms-of-service-for-candidates/
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Reg Affairs Manager

Job description

Job requirements

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