Regulatory Affairs Supervisor-(Hybrid Role) Parkmore Galway

2 weeks ago

Galway, Galway, Ireland TN Ireland Full time

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Regulatory Affairs Supervisor - (Hybrid Role) Parkmore Galway, Galway

Client:

Location: Galway, Ireland

Job Category:

Other

EU work permit required:

Yes

Job Reference:

7750d0a6f3a7

Job Views:

9

Posted:

15.03.2025

Expiry Date:

29.04.2025

Job Description:

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. At Integer, our values are embedded in everything we do.

Customer

We focus on our customers' success. We create better solutions. We create success together.

Inclusion

We always interact with others respectfully. We are open and honest with one another.

Integrity

We do the right things and do things right.

JOB SUMMARY

The Regulatory Affairs Supervisor will primarily be responsible for:

  • Ensuring compliance to all relevant regulations.
  • Supporting company goals and continuous improvement initiatives.
  • Preparing and supporting vigilance on regulatory data related to the company's range of medical devices.
  • Maintaining site Regulatory Affairs compliance, based on cGMP per requirements as defined in FDA 21CFR820, ISO 13485, MDD, AIMD, CMDCAS, MOR, and other International Regulations.
  • Acting as the site deputy 'Person Responsible for Regulatory Compliance' (PRRC) per Integer PRRC Policy.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES

Employees are expected to support the quality concepts inherent in the business philosophies of Integer including a variety of job-related tasks which may not be specific to this position profile.

Accountabilities include:

The Regulatory Affairs Supervisor is responsible for:

  • Development, collation, and review of data for US FDA regulatory submissions: PMAs, 510(k) registration.
  • Development, collation, and review of data for EU MOD, AIMD, and MOR Design Dossiers for submission to Notified Body, maintaining currency of CE Technical Files aligned with device and process changes.
  • Being a key member of the R&D and NPI teams, design control teams, and site engineering projects to ensure device compliance with appropriate International Regulatory requirements.
  • Developing regulatory strategies to support NPI and R&D projects.
  • Interpreting new or revised medical device regulations and standards, developing internal procedures to ensure continuous compliance with all regulatory requirements.
  • Ensuring all customer regulatory requests are addressed in an efficient and effective manner.
  • Supporting activities for FDA inspections, ISO 13485 audits, Competent Authority audits, Corporate audits, and Customer audits, and following through on close out of any subsequent actions assigned.
  • Maintaining Risk Management Files in line with real-time PMS data, device, and process changes.
  • Supporting reviews of Change Request Notes for change impact on regulatory filings, and updating latter where applicable.
  • Communicating with Notified Body, Competent Authority, and international regulatory authorities regarding license applications, CFS updates, and vigilance and compliance issues.
  • Completing reportability decision trees in relation to EU, US, Canada, and other jurisdictions when defined in the quality agreement with the customer.
  • Acting as facility lead for all post-market surveillance activities including field safety corrective action.
  • Performing regulatory review of product labeling and IFU, providing PMAP review.
  • Supervising regulatory affairs personnel including maintaining core records for all direct reports and raising issues concerning timekeeping should they occur, carrying out regular 1:1 meetings with reports as well as mid-year and annual reviews.
  • Ensuring that in your absence (or absence of any of your reports), your areas of responsibility provide adequate day-to-day service and ensuring that other departments know of your arrangements well in advance.
  • Assisting in complaint and CAPA investigation and root cause analysis, and performance of effectiveness activities.
  • Ensuring complaint activities are performed in a timely manner including reportability reviews, Health Risk Assessments, and submissions as required.
  • Attending project meetings as required.
  • Working efficiently using own initiative, escalating decisions to the Quality Manager as, when, and only when, necessary.
  • Being an active member of the Integer team and working with all employees to develop a world-class lean manufacturing system.

SKILLS AND KNOWLEDGE:

  • Knowledgeable in ISO 13485, US FDA 21 CFR Part 20, Canadian Medical Device, MOD, AIMD, and MOR requirements.
  • Ability to communicate and work with people inside and outside the department.
  • Ability to supervise.
  • Ability to coordinate, plan, and organize.
  • Excellent attention to detail and organization skills.
  • Ability to work to deadlines and on own initiative.
  • Excellent verbal and written communication skills.
  • Working knowledge of Excel and Word.
  • Experience with USA regulatory requirements would be advantageous.

MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS:

  • College graduate with Engineering or science degree or equivalent experience.
  • Minimum of 3 years' experience in a Medical device regulatory affairs role.
  • Competent in preparing written communication and correspondence.
  • Ability to make verbal presentations and effectively negotiate with regulatory, technical, medical, and legal professionals.
  • Comprehension of engineering principles adequate to allow participation in New Products Development and field complaint issues.
  • 3 - 5 years' experience in a regulatory affairs role in the pharmaceutical, healthcare, or medical device sector essential, preferably in an FDA regulated environment.

PHYSICAL & MENTAL DEMANDS:

  • Work effectively with close tolerances.
  • Ability to coordinate, plan, and organize based on priorities.

U.S. Applicants: EOE/AA Disability/Veteran

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