Manager of Regulatory Affairs

Location: Rochester, NY

Scope of the Job:

This position is located at corporate headquarters in Rochester, NY and reports to the Director, Regulatory Affairs. Your primary responsibility will be to provide regulatory affairs management for various Class II and III medical device projects to include 510(k), PMA, IDE, as well as label and advertising review and other regulatory affairs support activities.


Responsibilities Include:

Develop Regulatory strategies and timelines for product development and product improvement projects.

Lead and prepare US and non-US product submission projects such as 510(k), PMA, IDE and CE technical files. This requires participation in product development teams, as well as, responsibility to review, analyze and comment on technical reports.

Provide review and guidance of failure Investigations and corrective actions referred to Regulatory Affairs. Provide guidance on regulatory compliance.

Review, approve and provide guidance for labeling and advertising of device products. Counsel technical and business groups to establish direction based on available data and regulatory considerations.

Assist in Regulatory Agency inspections and preparedness activities. Interact with US and non-US government officials on product approval and compliance issues.

Review and provide input on departmental policies and procedures.

Provide input and comment to regulations and standards which may affect device products. Participate in industry working groups on advocacy initiatives.

Provide coaching/mentoring to regulatory specialists related to design control requirements and labeling requirements as well as content of product submissions.

Candidate Requirements:

1. BA/BS Degree in a technical or scientific discipline such as biology, chemistry, physiology, engineering, medical or law. An advanced degree and RAC Certification is highly desirable.

2. 5+ years of experience in Regulatory Affairs in a medical device setting with demonstrated experience preparing submissions for US Class II/III medical devices. Experience with contact lenses and experience preparing non-US medical device registrations is highly desired.

3. For the best fit you should be a collaborative team player who is engaging and welcomes the opportunity to mentor junior team members.

Send Resume and Cover Letter to:

Tracy Wolfe

Phone: 512 327-7277

6601 Carrington Drive Austin, Texas 78749
Phone: 512-327-7275 Fax: 512-327-1774
E-mail: Website: