Regulatory Affairs Specialist

Aequor; Warsaw (IN); On-site; USD 70,000 - 100,000; Full time

Job summary

Aequor, based in the United States, seeks a Regulatory Affairs professional to assist in filings, submissions, and regulatory strategy for medical devices.

The role requires understanding of FDA/EU regulations and collaboration across product teams to ensure compliant product development and labeling.

Qualifications

• Bachelor’s degree in life sciences, engineering or related field.
• Minimum 3 years in Regulatory Affairs, Engineering, or Quality.
• Regulatory Affairs Certification (US or EU) preferred.

Responsibilities

• Assist with regulatory filings and electronic submissions as needed.
• Assist with assembly, storage, tracking and retrieval of regulatory information.
• Respond to requests from foreign governments and distributors as needed.
• Assist with research, analysis and communication of regulatory pathways for new or modified products.
• Provides regulatory direction to development project teams and develops regulatory strategy.
• Evaluate risk of proposed regulatory strategies and offer solutions.
• Reviews labeling for compliance with global regulations.
• Writes and manages development of package inserts.
• Reviews promotional materials for regulatory compliance.
• Reviews proposed product changes for regulatory impact on status.
• Communicates with regulatory and governmental agencies.
• Applies FDA regulations to business practices and provides regulatory input to design teams.

Skills

Strong writing and communication

Interpersonal skills

Attention to detail

Knowledge of orthopaedic industry

Regulatory regulations knowledge

Relationship building across org

MS Office / basic computer skills

Education

Bachelor’s degree in life sciences/engineering or related field

1 year experience in orthopaedic/medical device preferred

3 years experience in Regulatory Affairs/Engineering/Quality

Regulatory Affairs Certification (US or EU) preferred

Education + experience considered

Job description

Responsible for assisting the team with regulatory filings as necessary to market our client's products. This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory submission process.

• 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
• 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