Regulatory Affairs Specialist - Class III Medical Devices

OLSA Resources, Inc.; Santa Clara (CA); On-site; USD 80,000 - 120,000; Full time

Job summary

OLSA Resources, Inc. is seeking a Regulatory Affairs Specialist based in California, Missouri, responsible for managing government interactions concerning approval processes for medical devices. Candidates should possess extensive experience in authoring PMA supplements and knowledge of FDA guidance.

The ideal candidate will need an advanced degree, with 5-8 years directly related to the regulatory field, especially with Class III implantable devices.

Qualifications

• 5-8 years of direct experience in regulatory process.
• Proven successful track record of submitting PMA supplements.
• Extensive experience in the field of implantable medical devices.

Responsibilities

• File applications and handle government interactions for product approval.
• Authorize and submit PMA supplements.
• Review engineering study protocols and manufacturing changes.

Skills

Authoring PMA supplements

Knowledge of FDA PMA guidance documents

Experience with Class III implantable medical devices

Regulatory interactions

Education

Advanced degree

Job description

Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports). Review/approval of engineering study protocols/reports and validation study protocols/reports. Review and approval of manufacturing changes for Class III implantable medical devices. May require an advanced degree and 5-8 years of direct experience in the field. Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. May lead and direct the work of others. A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department.

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