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9 Linnell Cir
Billerica, MA 01821
United States




RA Technical Writer

A growing medical device manufacturer of ophthalmic products is looking for a self-motivated individual to fill a full-time position in our regulatory affairs department.

Responsibilities (including, but not limited to):
• Prepares high quality regulatory submissions and supporting documentation for marketing applications.
• Reviews, edits, and inspects technical documentation to ensure continued compliance with regulatory requirements.
• Assists in the development of new product labels and IFUs and reviews current labeling for accuracy and completeness.
• Gathers, reviews, interprets, and prepares reports on post market surveillance activities.
• Develops, organizes, writes, and edits quality system standard operating procedures and records.
• Participates in regulatory surveillance audits and inspections (e.g. FDA, Notified Body)

Position Requirements:
• BA/BS in English, Journalism, Technical Writing or equivalent with a specialty in editing and writing. Minimum 1-2 years of relevant work experience.
• Excellent written and verbal communication skills, computer skills (Word, Excel, PowerPoint, etc.).
• Strong attention to detail (e.g. document style, consistency, grammar, and punctuation).
• Ability to interpret statistical data and prepare reports.
• Excellent analytical, organizational and time management skills.
• Experience in cross-functional collaboration.
• Experience producing high quality technical documents is a plus.
• Knowledge of ISO Standards, Quality System Regulations and European Regulations and Directives is a plus.
• All candidates must successfully pass a background check.

To Apply: Email resume to or send a fax to (978) 667-9778.

Entry-Level Lab Technician

Position Overview: Seeking a reliable temp-to-perm technician comfortable with performing lab duties in a clean room environment. Preferred individual possesses excellent manual dexterity, an eye for detail and the ability to take direction.

- HS Diploma or equivalent, with the ability to read and follow detailed instructions.
- No Bachelor’s Degree required, will consider individuals with an Associate’s Degree.
- No experience necessary, we will train individuals on all lab duties.
- Must be able to lift 35lbs.
- Basic math skills are required.
- All candidates must successfully pass a background check.

To Apply: Email resume to or send a fax to (978) 667-9778.