Regulatory Affairs Specialist

Merck & Co.; Warsaw (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

Merck & Co. in Warsaw, IN is seeking a Regulatory Affairs Specialist for a 1-year contract onsite. The role supports regulatory submissions, information management, and liaises with regulatory authorities and distributors to ensure compliance.

The ideal candidate has a life sciences background, 3+ years in Regulatory Affairs or related fields, and knowledge of FDA/EU regulations. A CRS is preferred, with strong writing and cross-functional collaboration skills.

Qualifications

• Bachelor's degree in life sciences or related field required
• Minimum 3 years in Regulatory Affairs, Engineering, QA or related field
• Regulatory Affairs Certification (US or EU) preferred

Responsibilities

• Assist with regulatory submissions and information management
• Respond to regulatory authority and distributor inquiries
• Assess regulatory pathways for products and communicate strategy
• Provide regulatory input to development teams and projects
• Review labeling, packaging inserts, and promotional material for compliance
• Ensure regulatory status considerations during product changes
• Communicate with agencies under supervision
• Apply FDA/EU regulations to business practices and design teams

Skills

Strong writing

Regulatory knowledge

Communication

Attention to detail

Cross-functional collaboration

Regulatory research

Problem solving

MS Office

Education

Bachelor's degree in life sciences/engineering

1 year orthopaedic/medical device industry experience (preferred)

3+ years Regulatory Affairs/related field

Regulatory Affairs Certification (US/EU) preferred

Job description

Regulatory Affairs Specialist
1 Year Contract
Warsaw, IN (100% Onsite)

Duties

• Assist with assembly, distribution, storage and tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process. May author and publish electronic submissions.
• Respond to requests from foreign government and/or distributors as needed
• Assist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products
• Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products
• Evaluate risk of proposed regulatory strategies; may offer solutions
• Reviews proposed labeling for compliance with applicable global regulations
• Writes and manages the development of package inserts
• Reviews and evaluations promotion and advertising material for compliance with applicable regulations
• Reviews proposed product changes for impact on regulatory status of the product
• Communicates with regulatory and governmental agencies with supervision
• Applies FDA regulations to business practices and provides regulatory input, advice and guidance to design teams

Skills

• Strong writing, communication, and interpersonal skills
• Strong attention to detail; ability to multi-task and balance competing priorities
• Knowledge of overall business environment, the orthopaedic industry, and the marketplace
• Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products as needed, based on functional area
• Ability to building relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels
• Knowledge of FDA, EU, and other regulatory body regulations
• Ability to identify risk in Regulatory strategies
• Strong problem solving skills
• Effective negotiating skills
• Basic computer skills, including Microsoft Office Suite

Education

• Bachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred
• A minimum of one year of experience in orthopaedic or medical device industry preferred
• A minimum of 3 years of experience in Regulatory Affairs, Engineering, Quality, or related field required
• Regulatory Affairs Certification (US or EU) preferred
• A combination of education and experience may be considered
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