Senior Specialist, International Regulatory Affairs

 

Overview

 

The Senior Professional Regulatory Affairs implements and monitors regulatory programs and assists in the homologation of the product range.

 

 

What you’ll do:

 

• The Senior Regulatory Affairs (RA) Specialist - International will plan and execute global regulatory activities necessary to obtain and maintain regulatory approvals within International markets.
• This position ensures compliance with required global regulations and serves as a key team member and/or in a lead role on extended team(s)
• Develop and execute global regulatory activities necessary to obtain and maintain regulatory approvals in International markets (such as, LATAM, EMEA, APAC and Canada)
• Provide support to local In-country RA affiliates who interact with regulatory authorities to assure timely approvals and continued product access
• Prepare submissions, interact effectively with regulatory agencies and negotiate submission issues as needed
• Participate and represent OUS regulatory function in sustaining and new product development projects to provide OUS regulatory requirements
• Assist in keeping company informed of regulatory requirements and external standards in International markets
• Prepares International submissions and obtain product approval/clearance to include assistance with government queries and registration documentation requirements
• Supports International product demand planning and release activities
• Reviews Change Orders and assess regulatory impact of product changes on International regulatory strategy and submissions per standard procedures
• Supports post market regulatory compliance activities for International product approvals
• Develops and maintains regulatory affairs department procedures and process improvements
• Other duties as assigned or required

 

Additional Key Responsibilities

• Provides input to assure that applicable country regulatory requirements including EU MDR regulations and standards are incorporated in the product development process and design/ manufacture of the products.
• Review and assess the RA inputs document in order to discuss the project and its scope and determine country-specific requirements such as testing requirements, labeling requirements as part of the Regulatory Inputs Documents.
• Produce subsequent submissions (License Renewals, Annual Reports, Additional Information Requests, etc.) to facilitate the maintenance of these approvals.
• In conjunction with Clinical Research, help in the preparation of applications (i.e. IDE) for conducting clinical investigations, as required. Generate required submissions (progress reports, etc.) to support the continuation of clinical studies.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
• Ensure compliance with pre-market and post-market approval requirements.

 

 

Travelling Requirement: Up to 10%

 

What you bring to the team:

 

 

Education

• Bachelor’s Degree (and/or 8-10 years of equivalent work experience)

Nice to Have

• Bachelor's degree in a technical or scientific field (e.g., Biochemistry, Biomedical, Electrical, or Chemical Engineering), or equivalent practical experience

 

 

Further Education

Nice to Have

• M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).

 

 

Work Experience

• 5-8 years of experience in pre/post market medical device regulatory affairs
• Experience in global regulations and maintaining certifications for the life of a medical device
• Experience leading cross-functional teams
• Experience providing regulatory strategy and guidance for Outside US and EU markets, (MENA, APAC, LATAM)

Nice to Have

•   Experience interacting with regulators during the market approval process.

 

•   Experience providing regulatory support for products under development (e.g., classification assessments, review engineering documents, risk analyses, test protocols and reports).

 

 

Personal Competencies

• Good working knowledge of Global regulations and standards.
• Excellent writing, proof reading and data management skills
• Excellent time management and problem solving skills
• Ability to adapt to different roles, responsibilities and context.
• Ability to change priorities and direction when necessary

 

 

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