Position Title
Regulatory Affairs Specialist
SBU
OEM
Department
Regulatory Affairs
Relocation Covered
Potential
Educational Requirements
Bachelor's degree
Experience Requirements
Proficient with Microsoft Office Products: Excel, PowerPoint, Outlook, Word, Access, Project, and Visio
Excellent oral and written communication skills
Strong presentation and training skills
Strong interpersonal, logic and planning skills
Excellent time-management skills with the ability to work independently with little supervision.
Ability to create and follow documented procedures and standards
Excellent organizational skills including the ability to keep accurate records
Ability to successfully perform multiple tasks in a fast-paced environment
Excellent negotiating and problem resolution skills
Strong research and technical writing skills.
Qualification Requirements
BS degree in a technical discipline
Minimum of 3 years experience in FDA regulated industry.
Regulatory experience supporting development and manufacturing of medical devices and/or combination products
Experience preparing 510(k) submissions, technical files, and/or design dossiers
Broad regulatory knowledge base, including global requirements for: submissions, marketing approvals, licensing, registrations, and renewals
Knowledge and experience with Quality Systems, such as, complaint handling; adverse event reporting; change assessment; recalls; labeling; and design control is preferred.
Experience interacting with regulatory authorities relative to premarket and compliance activities.
Preferred Qualifications
Regulatory certifications a plus, e.g., RAC, CQA, CQE, CQM
Regulatory experience with contracting manufacturing relationships
Working knowledge of international submission process
Experience with project management.
Responsibilities
The Regulatory Affairs Specialist is responsible for managing all aspects of regulatory affairs associated with the OEM business unit, including but not limited to, technical file review, labeling review, and design control review. This position will complete Regulatory Strategy documents for US, Canadian, and EU submissions; will be responsible for supporting and participating in the management of interactions with the US FDA, Health Canada, Notified Bodies (ISO), and other global regulatory authorities; and will support and participate in interactions with OEM customers’ Regulatory Affairs representatives to support global submissions and resolve issues. The Regulatory Affairs Specialist will also need to stay abreast of evolving global regulatory requirements.
Primary accountability for all US, Canadian, and EU submissions for the specific business unit, as assigned.
Responsible for determining the impact of scientific and technical information on submissions.
Ensure compliance with product development and design control procedures during development activities.
Coordinate categorization of all significant changes, evaluate and approve planned changes
Address and advise facility personnel on regulatory requirements for pathways to market
Work directly with Regulatory Affairs Manager to promote agreement on filing strategies or resolve problems with regulatory authorities.
Provide regulatory advice to project teams and ensure implementation of regulatory strategies
Analyze regulatory requirements for new or significantly changed products and author any necessary marketing approvals
Provide guidance on Quality and Regulatory coverage, risks and requirements to the OEM customer care group.
