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Regulatory Affairs Specialist-Parkmore Galway

1 month ago

Galway, Galway, Ireland Integer Holdings Corporation Full time

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

Innovation

We create better solutions

Collaboration

We create success together

Inclusion

We always interact with others respectfully

Candor

We are open and honest with one another

Integrity

We do the right things and do things right

JOB SUMMARY

The RA Specialist will primarily be responsible for ensuring compliance to all relevant regulations which includes maintaining all quality systems and related documentation. 

Key role of this position is to support company goals and continuous improvement initiatives, prepare and support vigilance on regulatory data related to the company's range of medical devices. Maintains site Regulatory Affairs compliance, based on cGMP per requirements as defined in FDA 21CFR820, ISO 13485, MDD, AIMD, MDR, CMDCAS and other International Regulations.

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 RA Specialist 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 MDD Class III Design Dossiers for submission to Notified Body, maintain currency of CE Technical Files aligned with device and process changes. Key member of the MDR project team Key member of the R&D and NPI teams, design control teams and site engineering projects to ensure device compliance to appropriate International Regulatory requirements. Actively support projects from new product introduction (NPI) and R&D and develop regulatory strategies Actively support the sales and marketing team and develop regulatory strategies where required Interpret new or revised medical device regulations and standards, develop internal procedures to ensure continuous compliance with all regulatory requirements Ensure all customer regulatory requests are addressed in an efficient and effective manner Support the preparation and activities for:FDA inspections,ISO 13485/MDSAP auditsCorporate auditsCustomer audits

And follow through on close out of any subsequent actions assigned. 

Maintains Risk Management Files in line with real time PMS data, device and process changes. Participate in Clinical Evaluation activities Support review of Change Requests for changes which may impact regulatory filings Support review of changes which may impact customers. Communicate same to customer and follow up to closure. Communicate with Notified Body, Competent Authority, and international regulatory authorities regarding license applications, CFS updates, and vigilance and compliance issues Support post market surveillance activities including field safety corrective action Performs regulatory review of product labelling and IFU Assist in CAPA investigation and root cause analysis, and performance of effectiveness activities. Project meeting attendance as required. Work efficiently using own initiative, escalating decisions to the Quality Systems and Regulatory Supervisor as, when, and only when, necessary. Be an active member of the Integer team and work with all employees to develop a world class lean manufacturing system Complaint investigations for completion of reportability decisions trees. Submission of MDR and MDVR adverse events to the relevant competent authorities and notified bodies. Be a key member of the internal audit team Makes decisions that are aligned with management objectives regarding work processes, plans and schedules to achieve quality objectives. Resolves project issues by working with team members, management, etc. Assists department and project leaders in developing and reporting appropriate performance and quality metrics. Performs other duties assigned as needed

SKILLS AND KNOWLEDGE:

Strong communication skills (written and verbal). Ability to co-ordinate, plan and organize Ability to work in a fast paced environment Excellent attention to detail and organization skills. Ability to work to deadlines and on own initiative. Computer literate, working knowledge of Excel and Word. Experience with USA regulatory requirements and EU MDR requirements would be advantageous. Negotiation and strong problem solving skills. Ability to communicate and operate effectively with multiple teams. Good technical report writing skills. Adapt to shifting priorities, work with minimal supervision, able to resolve problems/conflicts, reasoning ability

MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS:

College graduate with Engineering or Science degree or equivalent experience. Qualified systems lead auditor for ISO 13485 and MDD compliance is preferred. 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. Minimum 2years 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 in a fast paced demanding environment Ability to co-ordinate, plan and organise based on priorities.

Hybrid Role:

Required on site three days a week

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