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**Job Function: **
Regulatory Affairs Group
**Job Sub Function: **
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
Galway, Ireland
Job Description:
The Associate Regulatory Affairs Specialist 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. This role provides exposure to global regulatory processes and offers opportunities to develop technical regulatory expertise.
DUTIES & RESPONSIBILITIES
Under close supervision, and with guidance from senior Regulatory Affairs staff, and in accordance with all applicable international, federal, state, and local laws, regulations, requirements, as well as Corporate Johnson & Johnson procedures and guidelines:
Supports the preparation, compilation of regulatory submissions of technical and scientific medical device product information to US FDA, EU Notified Bodies, and other government regulatory agencies. Assists in the preparation of responses to regulatory authority queries and deficiency letters.
Supports regulatory submission activities including, but not limited to510(k), IDE, PMA, HDE, PMA/HDE Annual Reports, Technical Documentation Assessments, Design Examinations, Change Notifications (EU/UK), and other correspondence for new products and changes to existing products.
Support 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.
Support reviews proposed labelling, packaging, and promotional materials to evaluate conformance to applicable global market regulations.
Completes assigned duties in compliance with all International, Federal, State, local and Company regulations, requirements, policies, and procedures.
Collaborates with others:
Participates in 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.
Supports collaboration with other Regulatory team members in preparing and documenting communications (verbal and written) with FDA, EU Notified Bodies, and other external regulatory agencies.
Supports sharing required technical and regulatory informationto global partners to obtain local regulatory impact, and to complete required regulatory submissions.
Provides Regulatory Affairs support for internal and external audits to comply with ISO 13485 and related standards.
EXPERIENCE AND EDUCATION
- Education: Bachelor’s degree required; relevant industry experience is a plus.
- Alternatively, a graduate degree (MS or PhD) in a scientific, engineering, or related discipline.
- Preferred: Training in US and/or EU medical device regulations.
EXPERIENCE AND SKILLS
- Strong written and verbal communication skills, especially for conveying technical, scientific, and medical information in multiple technology formats and to different audiences.
- Some knowledge of US and European regulatory processes.
- Experienced in working as a member of a team.
- 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.
ADDITIONAL POSITION REQUIREMENTS
- Preferred: Practical experience in a medical device regulatory environment
- Preferred: Practical experience working within a medical device quality system
- Preferred: Practical experience preparing submission for Class II and III medical devices in the US and EU
- Language requirement: Proficiency in speaking, reading, and writing in English.
RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS
- Works with other departments such as Research and Development (R&D),, medical affairs, clinical, Marketing, Supply chain and other functions to achieve business objectives.
PHYSICAL WORKING CONDITIONS / REQUIREMENTS
- This position does not involve conditions that may require special or unique physical abilities
LOCATION & TRAVEL REQUIREMENTS
- Expected domestic and international travel: 5%–10%
**Required Skills: **
Preferred Skills:
The anticipated base pay range for this position is:
€34,800.00 - €55,775.00
Benefits:
In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.