Position Scope:

This role supports the regulatory registration of Anika’s products worldwide and contributes to global expansion business plans by assessing regulatory requirements in various international markets for company’s products. The Senior Manager, International Regulatory Affairs collaborates with associates outside the US and EU to achieve rapid worldwide registration of products by providing all documents needed for such efforts and supports continued registration of marketed products on a worldwide basis. This role works with the Regulatory Affairs department to standardize processes and procedures and work on process improvements to streamline registration request completion.

Responsibilities:

• Establishes strategy and manages international registration activities for Anika’s targeted international markets
• Collaborates with Business Leads to achieve rapid worldwide registrations
• Supports continued registration of marketed products on a worldwide basis
• Identifies and communicates potential risks and mitigations associated with regulatory strategies to stakeholders
• Participates in interactions/negotiations with international regulatory agencies when needed
• May guides one or more associates or contractors to handle registration requests and associated documentation
• Monitors regulatory developments affecting Anika products and communicates emerging opportunities and concerns to stakeholders
• Identifies, standardizes and implements improvements in product registration processes
• Manages global product submissions with an in-depth understanding of advanced
• technical/scientific principles that relate to multiple diverse and complex product lines and/or manufacturing processes
• Respond to and track the additional information requests from international regulatory agencies and/or distributor representatives
• Develops and maintains departmental procedures (SOPs & Work Instructions) for international product registrations
• Independently coordinates and collects specific registration information with R&D, Manufacturing, QA, and other applicable departments as necessary.
• Coordinates timely preparation of request for Certificates for Foreign Government, Certificates of Manufacturing and Free Sales, and Certificates for Exportability
• Monitors and compiles impact assessments of product changes (ACRs) for outside the U.S and EU.
• Carries out the above tasks with minimal supervision

Job Complexity:

Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends. Follows processes and operational policies in selecting methods and techniques for obtaining solutions.

Supervisory Responsibilities:

None

Requirements

• 7-10+ years Regulatory Affairs experience in medical device companies; preferred experience drug/device combination products and orthopedic devices
• B.A./B.S. degree or higher in a technical discipline, preferable in engineering, bioengineering, biology, or chemistry desired or equivalent experience.
• Experience with international submissions for medical device and drug regulatory required
• Experience supporting product development and/or product support projects
• Experience working with in-country distributors on regulatory submissions preferred
• Ability to work autonomously; successful history of handling multiple projects, and prioritizing activities and managing deadlines
• Demonstrated ability to effectively communicate both verbally and in writing
• Experience maintaining confidential information at appropriate levels within the organization
• Regulatory Affairs Certification preferred