Regulatory Affairs Compliance Specialist

Regulatory Affairs Compliance Specialist

Gyrus ACMI

Southborough, MA

Please apply at:

Position Description:

Southborough, MA – The Regulatory Affairs Compliance Specialist will assist the Regulatory Affairs (RA) Compliance Manager in obtaining approval to market Gyrus medical devices in the worldwide markets served by Gyrus. EOE M/F/D/V

Requirements and Responsibilities:

* Participate in product teams developing new products to define global regulatory requirements.

* Review and approve product labeling and advertising and work closely with Marketing in developing labeling materials.

* Develop, coordinate, prepare, and maintain US medical device submissions such as 510ks, PMAs, IDEs, and applicable supplements and annual reports. Liaise with FDA reviewers as needed.

* Develop, coordinate, prepare, and maintain international medical device submissions such as EU design dossiers and technical files and Canadian Class 3/4 submissions and product registrations in markets such as Japan, the Far East, Australia, and Latin America.  Respond to regulatory authorities and/or distributor’s requests for additional information.

* Interface with foreign distributors and international regulatory authorities and notify bodies as necessary to ensure Gyrus products comply with country requirements.  Work closely with the International Marketing Department to implement Gyrus business plans.

* Obtain Certificates of Product for Export or other applicable export notifications from the FDA as needed.

* Assist with the maintenance of regulatory files and tracking databases to ensure prompt and accurate access to Gyrus regulatory information and to provide reports to Management concerning current, pending, and future approvals.

* Keep abreast of changes and proposed changes to the worldwide regulatory requirements related to Gyrus products and processes. Advise Regulatory Management of changes and communicate regulatory initiatives or changes to other Gyrus staff.

* Assist with the tracking of external standards applicable to Gyrus products and processes, as well as the maintenance of the corporate standards library/index and communication of proposed/implemented changes to Gyrus staff.

* Assist in the development and maintenance of regulatory procedures to ensure consistent, efficient, and compliant regulatory processes.

* Secondary responsibilities include:

– Assisting with compliance activities related to GMP and ISO regulations and ISO quality system standards

– Assisting in the performance of internal quality and regulatory compliance audits and the evaluation and monitoring of corrective actions

– Assisting Managers during quality inspections by FDA and International Regulatory Agencies

– Responding to requests for information during inspections

– Reviewing product and process documentation for assigned projects to ensure compliance with change control requirements and determining whether regulatory submissions are required

* Perform other related duties as assigned.



* A Bachelor’s degree, preferably in Engineering or Life Sciences is required.

* Must have documented continuing education in Regulatory Affairs.

* RAC Certification is a plus.

* Regulatory affairs experience in the medical device industry is mandatory, with a minimum of 3-5 years of experience preferred.

* The ability to communicate effectively (verbal and written) and be proficient in Microsoft Office (Word, Excel or Access, and PowerPoint) is essential.

* Must be able to work in small team environment, but must also be self-starter with the ability to work independently.

* The ability to work on problems of a diverse scope where the analysis of a situation or data requires an evaluation of various factors is necessary.

* Must be able to meet deadlines and be detailed orientated. Good planning and organization skills are a must.

* Strong critical thinking and problem solving skills are vital.

* Must be able to travel to Gyrus facilities in the US.

* The following physical demand is required:

– Stand/sit/walk 8 hours per day

Please apply at: