Address
Form of work
SalaryRegulatory Affairs Co-op
Regular Full-Time Hourly
Manchester, NH, US
POSITION SUMMARY:
An entry level position implementing and maintaining the Regulatory and Quality requirements within the company including product registration and listing, environmental data, audits, continual improvement, and performance monitoring to ensure objectives and targets are met. During this co-op you will receive training and mentoring related to new tasks as they come up in normal operations.
ESSENTIAL DUTIES and RESPONSIBILITIES:
- Provides regulatory affairs support for all aspects of product development and manufacturing.
- Regulatory maintenance on medical device designs.
- Customer EU-MDR data requests and certifications.
- Reach, RoHS, and Prop 65 analysis and certification.
- UDI 2D data matrix compliance with existing and new designs.
- Customer and regulatory body audits.
- Evaluate and process customer complaints.
- Design change regulatory assessments.
- EU-MDR design review and remediation.
- Other tasks as assigned by supervisor.
KNOWLEDGE and SKILLS:
- Polished interpersonal, documentation, and communication skills are a must.
- Confidence presenting to large groups both online and in person.
- Strong working knowledge of Microsoft Office.
- Knowledge of 21 CFR 814, 21 CFR 820, and other FDA guidance.
- Knowledge of ISO 13485.
- Ability to drive individual tasks and projects to completion.
EDUCATION and EXPERIENCE:
- Bachelor’s degree or equivalent combination of education and applicable job experience in the medical device industry.
- Familiarity with working in a regulated environment.
WORK ENVIRONMENT / PHYSICAL DEMANDS:
- Workers situated in an office environment could routinely use standard office equipment which may include computers, phones, photocopiers, filing cabinets.
- Workers exposed to the production floor could be frequently exposed to fumes or airborne particles, moving mechanical parts and vibration, and moderate to loud noise conditions.
- Ability to meet safety, regulatory and health guidelines without assistance.
- Ability to maneuver throughout the facility/facilities as needed.
- Ability to wear proper Personal Protective Equipment (PPE).
- Standing; walking; manual dexterity sufficient to reach/handle items and work with fingers.
