Regulatory Affairs Manager

Responsible for the hands on regulatory activities associated with bringing new medical device combination product to the US market. Projects are with significant complexity and may include developing recommendations on regulatory strategy for a product category or therapeutic area.

Major duties and responsibilities:

Manage regulatory activities that support the development of new and maintenance of existing commercialized products in US & EU.

Serve as Regulatory point of contact on project teams to develop regulatory strategies, milestones and submission deliverables for the development of new products.

Responsible for developing compliant labeling & product registrations

Preparation of regulatory plans and assessment per newest updates

Author Standard Operating Procedures (SOP) and Work Instructions (SWI) for Regulatory Affairs department, as needed. Includes the biannual review, and revisions, to existing SOPs and SWIs.

Monitor and interpret the impact of ongoing development in the regulatory environment and work with internal and external stakeholders on impact of new laws and regulations.

Support investigation of quality, product safety and / or regulatory issues arising from partners, customers, field, vendors and regulatory authorities. Support implementation of corrective actions and procedure improvements to resolve issues.

Competencies:

Background in medical device development

Experience with FDA and MDR submissions

Must possess advanced analytical skills, communication/writing, and critical thinking and the ability to identify and apply policies and general regulations to specific products and projects

Ability to monitor, analyze, raise awareness and assess impact of regulatory issues for stakeholders inside and outside of Regulatory Affairs

Ability to effectively lead project teams

Ability to work in a multi-disciplinary team

Proactive and self-motivated with a collaborative attitude and a desire to continuously learn.

Education and Knowledge Requirements:

Engineering degree in a health sciences field such as biochemistry, chemistry, pharmacy, pharmacology, or nutrition or food sciences combined

8+ years of experience in the health care or pharmaceutical industry and 8+ years of hands on experience in regulatory affairs.

Advanced degree preferred.