What are the responsibilities and job description for the Senior Regulatory Affairs Specialist (Bedford, MA) position at CEDENT?
Client is seeking a Senior Regulatory Affairs Specialist to develop, lead and execute a regulatory strategy for new products and global expansion. This is a terrific opportunity for an experienced medical device regulatory professional to grow with our company.
Responsibilities:
Responsibilities:
- Develop and implement regulatory strategies for new and existing products.
- Prepare amendments/supplements, new device applications, 510(k)s, technical documentation (EU MDR), and design dossiers.
- Maintain State of Art to global regulations (e.g., EU MDR, MDSAP).
- Lead regulatory efforts required to align with new regulations and requirements including changes to international standards.
- Serve as the voice of regulatory on cross-functional teams, including working with product development and manufacturing engineers to ensure regulatory requirements are incorporated throughout the product lifecycle.
- Collaborate with commercial teams to ensure regulatory compliance in product labeling, promotional materials, and advertising materials.
- Interact with regulatory agencies, including FDA and Notified Bodies, to facilitate product approvals and clearances.
- Bachelor's degree in Science, Engineering, Regulatory Affairs, or other technically related field.
- 5-8 years of experience in medical device regulatory affairs, including prior 510(k) submission and EU MDR experience. Experience with medical devices that include software and hardware systems is helpful.
- Experience with international regulatory requirements and standards, including MDSAP, EU MDR, and ISO 13485.
- Excellent communication, interpersonal and collaboration skills.
- Strategic thinking, attention to detail, and ability to manage multiple projects simultaneously.
- RAC certification is a plus.
