Matchtech

Regulatory Affairs Associate

Recruiter
Location
Fareham
Salary
Negotiable
Posted
24 May 2017
Closes
21 Jun 2017
Ref
EMP391062
Contact
Charlotte Hope
Sector
Biotechnology
Discipline
Mechanical
Contract Type
Permanent
Hours
Full Time
JOB SUMMARY

The Regulatory Affairs Assistant will assists in writing, filing, and obtaining approvals for domestic and international regulatory submissions. The Regulatory Affairs Assistant follows the regulatory strategy for assigned corporate projects.



ESSENTIAL FUNCTIONS

* Follows regulatory plans and interfaces with department and management.
* Assists in developing, implementing, and maintaining global regulatory procedures to ensure regulatory compliance.
* Assists in evaluating manufacturing changes for impact on global regulatory affairs approvals, clearances, registrations, and licenses.
* Assists in generating and maintaining global (domestic and international) regulatory submissions, i.e. PMA, PMA supplement, PMA Annual Reports, MDR, international licenses and registrations.
* Maintains regulatory files and documents, in addition to internal regulatory tracking documents. This includes maintaining communication with supervisor and other departments to provide regulatory status reports (monthly, quarterly, etc.)
* In addition to the required technical documentation, supplies samples, packaging, manufacturing site quality system certificates, and certificates of free sale, etc. for global product registrations.
* Keeps abreast of regulatory requirements, this includes monitoring FDA and other agencies regulations and standards.

POSITION QUALIFICATIONS

KNOWLEDGE, SKILLS AND ABILITIES

* Develops project management and technical writing skills.
* Effective communicator; able to convey messages in a logical and concise manner. Consistently reinforces regulatory expectations and requirements.
* Attention to detail with organizational skills.
* Independent self-starter; manages time effectively and completes tasks on-time with general supervision. Flexible and able to self-manage multiple priorities.
* Able to work effectively in multinational/multicultural environments.
* Works scheduled hours and is ready to work at scheduled start times. Adapts readily to changes in workload, staffing, and scheduling.
* Complies with all company policies and procedures.
* Complies with management direction. Seeks assistance from supervisor in identifying and reporting problems or concerns relating to job functions.
* Conducts self in a professional manner with coworkers, management, customers, and others. Models the corporate values.
* Mathematical, analytical, and computer skills.
* Develops working knowledge of domestic and international regulations; Must be proficient with MS Word Office Suite for PC, Adobe Acrobat XPro, MS Project, VISIO.
* Familiarity with Agile Project Lifecycle Management

EDUCATION

* Bachelors degree in a scientific or technical discipline from a four year college or university. Life science (chemistry, biology, pharmacy, biotechnology) preferred.
* Formal education in regulatory discipline preferred.
* Regulatory Affairs Certification, preferred

EXPERIENCE

* Some work experience in a Regulatory Affairs environment preferred (e.g. an internship) but not essential. Graduates will be considered.

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