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 Regulatory Affairs Supervisor will primarily be responsible for;
- Ensuring compliance to all relevant regulations
- 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, CMDCAS, MOR and other
International Regulations.
- Act 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:
- Development, collation and review of data for EU MOD, AIMD and MOR Design Dossiers for submission to Notified Body, maintains currency of CE Technical Files aligned with device and process changes.
- 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.
- Develop regulatory strategies to support NPI and R&D projects
- 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 and addressed in an efficient and effective manner
- Supporting activities for:
- FDA inspections,
- ISO 13485 audits
- Competent Authority audits
- Corporate audits
- Customer 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.
- Support reviews of Change Request Notes for change impact on regulatory filings, and update latter where applicable
- Communicate with Notified Body, Competent Authority, and international regulatory authorities
regarding license applications, CFS updates, and vigilance and compliance issues
- Completion of reportability decision trees in relation to EU, US, Canada and other jurisdictions when defined in the quality agreement with the customer
- Act as facility lead for all post market surveillance activities including field safety corrective action
- Performs regulatory review of product labelling and IFU, provides PMAP review
- Supervision of regulatory affairs personnel including:
- Maintain Core records for all direct reports and raise issues concerning timekeeping should they occur
- Carry out a regular 1:1 meeting with reports as well as a mid-year and annual review.
- Ensure that in your absence (or absence of any of your reports) your areas of responsibility provide adequate day to day service. Ensure that other departments know of your arrangements well in advance
- Assist in complaint and CAPA investigation and root cause analysis, and performance of effectiveness activities.
- Ensure complaint activities are performed in a timely manner including reportability reviews, Health Risk Assessments and submissions as required.
- Project meeting attendance as required.
- Work efficiently using own initiative, escalating decisions to the Quality Manager 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
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 co-ordinate, plan and organise
- Excellent attention to detail and organisation 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 co-ordinate, plan and organize based on priorities
- This role is Hybrid- On site 2 days a week, 3 days working from home
U.S. Applicants: EOE/AA Disability/Veteran