Specialist, Regulatory Affairs Surgical

About the role

Join us and be part of our inspiring journey. Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues, and/or reporting to management.

Responsibilities

• Prepare and oversee documentation packages for submission to global regulatory agencies.
• Track timelines and documents milestone achievements for inclusion in regulatory submissions.
• May interact with regulatory agencies as part of submission review and on-site audit support (e.g., IDE’s, PMA’s, annual reports, 510(k)’s, STED’s and CE marking design dossiers and technical files).
• Provide guidance on regulatory requirements necessary for contingency planning.
• Monitor proposed and current global regulations and guidance; assesses impact of such regulations and guidance on assigned project(s); proposes suggestions on utilizing regulatory updates to expedite approval process.
• Review labeling content, product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracy.
• Prepare documents for submissions, including assuring the appropriate forms for all of the global regulatory bodies; assist with GUDID submissions.

Requirements

• Bachelor's Degree & a minimum of 3 years related experience or equivalent experience based on Edwards criteria.
• Coursework, seminars, and/or other formal government and/or trade association training.

Preferred

• Bachelor's Degree in scientific discipline (e.g., Biology, Microbiology, Chemistry, Bioengineering).
• Experience in preparing domestic and international product submissions.
• Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices.
• Solid knowledge and understanding of global regulatory requirements for new products or product changes.

Benefits

Competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $74,000 - $104,000 (highly experienced).