The Regulatory Affairs Specialist works with a team to develop and execute international strategies for regulatory approval of medical device products. The person in this role will work as assigned in these areas:
- Coordinates, compiles and submits U.S, and/ or International regulatory submissions, including filing and/or creation of 510Ks, PMAs, IDEs, Premarket Notifications, Supplements, Change Notifications, and other country-specific product registrations.
- Develop IDE/ 510K/ PMA (US) and Technical Files/ Design Dossiers (EU) submissions for class II and III medical devices.
- Manages the generation of documentation to be submitted to worldwide governmental regulatory agencies in order to secure approvals to market products
- Carries out Post Market Surveillance activities such as CAPA support, post market risk management, recalls, and complaint handling.
- Supporting basic and advanced market entrance, providing acquisition due diligence, UDIs, and clinical evaluation reporting (CERs).
- Reviews device labeling and marketing materials for compliance with FDA submissions and applicable regulations.
- Represents department on cross-functional product development and manufacturing support teams. Guide teams to provide content for US and/or International submissions, participates in design reviews as needed.
- Communicates with and maintain productive, constructive relationships with external customers as required – US FDA, Health Canada, in-country regulatory representatives, and notified-bodies.
- Participate in project development teams and review plans, reports, risk management and design reviews associated with product and process projects.
- Assist in regulatory due diligence for potential and new acquisitions
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
About Company Client:
- Grew Regulatory and Quality teams by double digits in 2018.
- Has a retention rate of over 95%.
- Hiring for direct hire roles, but may consider Contractors also.
- Offers generous company benefits to include health, dental, and vision insurance, 401K and disability insurance.
- Bachelors degree, or equivalent of education and experience sufficient to successfully perform the essential Bachelor’s degree required: bio-medical engineering or the life sciences highly preferred.
- Regulatory Affairs Certification (US or EU) preferred
- RAPS certification preferred
- 1-10 years of direct experience in regulatory and/or quality assurance, specific to medical devices.
- Works with others as a team player to successfully achieve strategy. Must be cooperative and work well with all functional groups.
- Initiative and ability to be self-directed, while thriving in a setting requiring collaboration and teamwork for maximal efficiency and effectiveness
- Ability to effectively respond to time sensitive issues and meet deadlines
- Ability to anticipate, quickly address and make correct decisions in a fast-paced, dynamic environment
- Ability to focus on multiple projects and re-establish priorities as necessary