Johnson & Johnson is recruiting for a Regulatory Affairs Specialist, MedTech Neurovascular, located in Galway, Ireland.
At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at https://www.jnj.com/ .
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.
Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world.
Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.
We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve.
Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
The Regulatory Affairs Specialist position offers the opportunity to have a significant impact on patient access to innovative neurovascular products around the world!
The role will primarily support regulatory activities to obtain and maintain medical device approvals / clearances in the US and European markets.
This role will support preparation, submission, tracking, indexing, and archiving of official documents and files such as Technical Documents, amendments/supplements, annual reports, general correspondence, promotional materials, and other EU or US regulatory submissions.
The individual will work closely with other Global Regulatory Affairs partners and with functional partners in Research and Development (R&D), Medical Affairs, Quality, Supply Chain, Marketing, and other functions.
Key Responsibilities: Under moderate supervision and in accordance with all applicable international, federal, state and local laws/regulations/requirements and Corporate Johnson & Johnson procedures and guidelines: * Supports the compilation of regulatory submissions of technical and scientific medical device product information to US FDA, EU Notified Bodies, and other government regulatory agencies; including but not limited to 510(k), IDE, PMA, HDE, PMA/HDE Annual Reports, Technical Documentation Assessments, Design Examinations, Change Notifications, and other correspondence for new products and changes to existing products.
* Completes assignments for the creation and maintenance of regulatory documents and records related to FDA submissions, Technical Documentation, Design Dossiers, Letters to File, regulatory impact assessment of changes, and other regulatory documents for medical devices, including US Class II and III devices and EU MDR Class III devices.
* Attends regular meetings with project teams for product development and product changes, communicating applicable regulatory requirements and activities needed to gain and maintain regulatory approval in various markets.
* Collaborates with other Regulatory team members in preparing and documenting communications (verbal and written) with FDA, EU Notified Bodies, and other external regulatory agencies.
* Communicates relevant technical and regulatory information to global partners to obtain local regulatory impact, and to complete required regulatory submissions.
* Reviews proposed labelling, packaging, and promotional materials to evaluate conformance to applicable global market regulations.
* Provides Regulatory Affairs support for internal and external audits.
* Completes assigned duties in compliance with all International, Federal, State, local and Company regulations, requirements, policies, and procedures.
Education: * 2 years of experience Preferred: * Training in US and/or EU medical device regulations.
Experience and Skills: Required: Successful candidate must be experienced in working as a member of a team.
They must have strong written and verbal communication skills, especially for conveying technical, scientific, and medical information in multiple technology formats and to different audiences.
They will have some knowledge of US and European regulatory processes.
They will also have the following: * Ability to communicate in a constructive manner to encourage new, diverse ideas so decisions can be made in alignment with business objectives and the J&J Credo.
* Capability to work in an environment of innovative thinking, informed risk taking, intellectual curiosity, and continual learning of regulatory developments.
Preferred: Practical experience in * a medical device Regulatory Environment * working within a medical device quality system * preparing submissions for Class II and III medical devices in the US and EU.
Other: * Language Requirement: Proficiency in speaking, reading, and writing in English.
* Domestic and International Travel 5-10% Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .]