- Development, collation and review of data for US FDA regulatory submissions:PMAs,510(k) registration
- Development, collation and review of data for EU MDR 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
- 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.
- 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
- 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
- College graduate with Engineering or Science degree or equivalent experience.
- 3 -5 years experience in a regulatory affairs role in the pharmaceutical, healthcare or medical device sector essential, preferably in an FDA regulated environment
- Qualified systems lead auditor for ISO 13485 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.
- Work effectively in a fast paced demanding environment
- Ability to co-ordinate, plan and organise based on priorities.
Senior Regulatory Affairs Specialist - Galway, Ireland - Integer Holdings Corporation
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
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 - Senior Regulatory Affairs Specialist (Hybrid)
The Senior RA Specialist will primarily be responsible for ensuring compliance to all relevant regulations and quality systems requirements for medical devices .
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 Senior RA Specialist is responsible for:
And follow through on close out of any subsequent actions assigned.
SKILLS AND KNOWLEDGE:
MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS:
U.S. Applicants: EOE/AA Disability/Veteran