Overview

This is a part time (20 hours / wk) position

In this position you will be responsible for assuring quality and regulatory compliance including complaint handling for Oticon Medical LLC, as a US agent and initial importer of Class II Medical Devices.

You will guide the business with respect to quality and regulatory affairs issues, complaint handling and initiatives to maximize the operational capacity of Oticon Medical's distribution of auditory implantable devices.

Internationally, the position works cross-functionally with Logistics and Quality Assurance at Oticon Medical's suppliers to ensure that product labeling is consistent with FDA approvals.

Locally, the position interfaces with purchasing, logistics and stock management to ensure quality compliance. You will also work closely with Marketing, Sales, and Legal to identify & interpret domestic US regulations such that promotion, labelling, and registration are compliant to US regulations.

Responsibilities

• Entering and monitoring of complaints in conjunction with the international team
• Review of all US marketing materials including patient and health care provider brochures, web content, health care provider training materials and clinical evidence packages as part of the market literature creation process.
• Maintains the company’s marketing claims matrix. Provides input to various layers of the organization including clinical affairs, professional marketing and consumer marketing on training and marketing materials to ensure that statements are supported by approved indications and relevant literature.
• Provides input to clinical research in evaluating studies for the need for an IDE track vs Non-IDE submission.
• Assists the business in recall planning and field corrections.
• Establishes and maintains registration and licensing of Oticon Medical LLC per Federal (., FURLs FDA site), State and Local guidelines for the scope of activities in which the company is engaged.
• Trains staff in regulatory policies or procedures
• Provides the business with competitive intelligence related to the regulatory approvals of competitive companies in the auditory implantable space.
• Oversees documentation efforts to ensure compliance with domestic and international regulations and standards as well as the ever-ongoing changes to standards.
• Host FDA audits as representative for Oticon Medical LLC
• Prepares, implements and supervises the compliance of quality procedures
• Drives definition and implementation of new efficient QMS processes to support the organisation.
• Identifies and utilizes QMS synergies between entities in the Demant group for smooth integration between collaboration partners
• Implementation of new standards and regulations
• Performs QMS trainings of the organisation
• Performs internal audits and audits of subcontractors
• CAPA handling
• Ensures document control
• Follows all company standards and procedures.
• May perform miscellaneous tasks / projects as directed by

Qualifications

• Bachelor's degree in Engineering Science
• Minimum of 3- 5 years’ experience in regulatory affairs in the medical device environment.
• Has good working knowledge of US regulations including the QSRs (part 820), Labelling, Recalls and Corrections etc. and international standards / processes including ISO13485 and CE marking
• Detail oriented and excellent organizational
• Strong communication skills - written and
• Ability to work under pressure in a fast paced and demanding

The Company is an Equal Opportunity / Affirmative Action employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.

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Last updated : 2024-04-24