Regulatory Affairs Specialist

General Job Description

Reports to and receives assignments, instructions and direction from the Director of Regulatory Affairs. Responsibilities include assistance in regulatory submissions, annual reports, registrations and listings, internal audits and government/supplier inspections. Employees will assure compliance with applicable medical device regulations per jurisdiction, guidance and standards and assist in creation and maintenance of regulatory files. Observes and follows all safety rules and procedures, including wearing required PPE.

Performs various other duties and activities as directed by the Director.
Must meet all elements of the Helena Standards Pertaining to All Jobs, Job Classification Standards – Job Requirements Matrix and General Job Requirements.

Experience in manufacturing operations or medical device industry, knowledge of ISO  Quality Management Systems Auditing and/or clinical experience. Relevant certifications considered but not required.

Bachelor’s Degree or country equivalent in Engineering or Science or related scientific discipline, or equivalent.

• Science knowledge must be able to digest complex data while keeping the big picture through good analytical skills.
• Excellent written and verbal communication skills with the ability to listen, articulate and advocate.
• Proactive, high performance, results oriented and manage projects with ethical integrity.
• Technical system skills (MS office applications, database efficient online research).
• Manage multiple projects and deadlines.
• Ability to identify compliance risks and escalation when necessary.
• Demonstrate both creative and critical thinking skills.

Employee must pass criminal background verification.

Yes

Typing, Calculations/Math and Proofreading

$45,760 - $49,920 per year

Helena Laboratories Corporation is an equal employment opportunity employer, offering equal employment opportunities to all individuals and will not discriminate against any employee or applicant for employment because of religion, sex, sexual orientation, gender identity, race, color, national origin, age, protected veteran status, marital status or disability. EEO/AA