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

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

Be responsible for developing compliant labeling & product registrations.

Prepare regulatory plans and assessments per newest updates.

Author Standard Operating Procedures (SOP) and Standardized Work Instructions (SWI) for the 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 investigations of quality, product safety and/or regulatory issues arising from partners, customers, the field, vendors, and regulatory authorities. Support implementation of corrective actions and procedure improvements for issue resolution.

Background in medical device development

Experience with FDA and MDR submissions

Advanced analytical skills, communication & writing skills, and critical thinking skills – a must

Ability to identify and apply policies and general regulations to specific products and projects – a must

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

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

8+ years of experience in the health care or pharmaceutical industry

8+ years of hands on experience in regulatory affairs