Senior Regulatory Associate - (US-MA-Mansfield - 02048)

Minimum Education: None
Jobcode: 56305334
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Establish effective dialogue with various members of the regulatory department and other disciplines within the organization. Prepares 510(k) Premarket notifications with the Food and Drug Administration (FDA). Assists in the planning and preparation of other domestic and international regulatory submissions including required correspondence and reports to regulatory authorities as defined in FDA Regulations, ISO 9001 Standards, ISO 13485:2003 Standard, Medical Device Directives (93/42EEC), Canadian Medical Device Regulations, and other international regulations. Facilitate timely product registrations and regulatory approvals. Organize and manage regulatory database(s).

Essential Duties and Responsibilities :

Primary responsibilities are:

Prepare 510(k) submissions.

Coordinate the translations of product labeling.

Compile and prepare documents for product approvals and registrations.

Gather data and assists in the preparation of other regulatory submissions to be filed with the US - FDA and International Regulatory Agencies. e.g. IDE, PMA, Annual Reports, Technical Files/Dossiers.



Prepare and maintain FDA Establishment Registrations and Device Listings; Organize and manage regulatory database(s) for product approvals and registrations.

Participates in regulatory audits and assists in the preparation of responses to audit findings or other actions as needed.

Research for regulatory data and information utilizing the worldwide web and other available resources.

Reviews new regulations, policies, guidance documents and other trade publications to stay informed with current changes that may impact company activities.

Participates in training and education seminars as appropriate to learn regulatory requirements.

Assists with regulatory training requirements relative to FDA, ISO, MDD, CMDR and other applicable regulations.

Assists in relevant project planning and review meetings.

Performs all other related duties as directed by management.

Education and Experience:

To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required for this job level. Any equivalent combination of education and experience that provides the applicant with the knowledge, skills, and abilities to perform the job is acceptable.

Education

Bachelor’s degree or equivalent work experience.

Type and Number Years of Experience

Knowledge of U.S. FDA and or International laws, regulations and standards and at least 1-2 years of experience in the preparation of regulatory submissions on medical devices.