We are looking for a RA Device Sr. Manager to be responsible for the hands on regulatory activities associated with bringing a new medical device combination product to the US market. Projects are complex, therefore responsibilities may include developing regulatory strategy recommendations for a product category or therapeutic area.
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
Feel free to send us your CV and we will keep you informed about new openings