CAREERS
| Regulatory Affairs Specialist |
| Date: November 2, 2011 |
| Reporting To:Senior Director of Regulatory Affairs |
| Department:Regulatory Affairs |
| Location:Inverin, Co. Galway, Ireland |
ESSENTIAL DUTIES AND RESPONSIBILITIES:
To perform this job successfully, an individual must satisfactorily perform each essential duty. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
1. Compiling medical device regulatory submissions (Technical Files, Design Dossiers, International) according to current regulatory guidance and regional requirements.
2. Monitoring the progress of regulatory submissions, responding to queries and ensuring that registration approvals are granted without undue delays.
3. Maintenance of medical device approvals in worldwide markets.
4. Assessment of change control documentation and submitting change notifications when required.
5. Establishing and maintaining good working relationships with internal and external partners to facilitate the accomplishment of regulatory and company goals.
6. Review and approval of artwork change controls ensuring artwork is in accordance with regulatory requirements/registration commitments.
7. Demonstration of flexibility – involvement in pharmaceutical regulatory submissions as determined by department needs.
8. Perform other duties as assigned.
QUALIFICATIONS
The qualifications listed below are representative of the minimum knowledge, skill, and/or ability required.
KNOWLEDGE
Pharmaceutical or Medical Device Regulatory Requirements for EU or US.
cGMP awareness and compliance.
SKILLS AND ABILITIES
Excellent communication skills, both oral and written.
Experience in writing and submitting regulatory documentation.
Strong organizational skills.
Good interpersonal skills.
Accuracy and attention to detail.
Ability to respond quickly to a changing regulatory environment.
Computer skills, E-mail (Lotus Notes) Microsoft Word, Excel, Powerpoint an advantage.
SUPERVISION
Position functions with supervision.
EDUCATION/EXPERIENCE
Minimum of a Bachelor's degree (or equivalent) in a science related discipline and 1-2 years’ experience working in a Regulatory Affairs department within a Pharmaceutical or Medical Device company.
However, a combination of experience and/or education will be taken into consideration.
LICENSES/CERTIFICATIONS
None required.
LANGUAGE SKILLS
Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with managers or directors and communicate ambiguous concepts. Ability to present to groups across the organization.
MATHEMATICAL SKILLS
Ability to rAbility to read, understand and interpret mathematical technical data.
REASONING ABILITY
Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.
Typically sitting at a desk or table. Intermittently sitting, standing, walking or stooping. Periodic travel is required.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.
Normal office situation.
TO APPLY
Please forward cover letter and CV to careers_bioniche@mylan.com
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