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Regulatory Affairs Manager

3 months ago

Bedford, United States Pramand LLC Full time

**About Us**:
Pramand, LLC, is a medical device company based in Bedford, MA. We develop implantable medical devices from novel, proprietary hydrogel materials that improve patient outcomes while lowering the cost of therapy. We self-fund our projects through preclinical development and work with financial partners for clinical development and commercialization. Our portfolio of hydrogel technology positions us to be the leader in creating new hydrogel based medical devices to address unmet medical needs in a range of surgical interventions. We have launched over ten medical device companies based on this unique technology. These companies have generated over $4B in value, and have helped over 5 million patients worldwide achieve better outcomes.

**Position Summary**:
The Regulatory Affairs Manager is responsible for developing and implementing strategies to ensure compliance with regulatory standards and requirements for Pramand’s medical device products. This role advises development teams, prepares regulatory documentation, and interacts with regulatory agencies to gain marketing approval for Pramand’s products in various territories.

**Principal Duties and Responsibilities**:

- Regulatory Strategy - Formulate and execute regulatory strategies to assure timely and successful product approvals. Provide regulatory guidance to crossfunctional teams to support product development and commercialization.
- Regulatory Submissions - Prepare and submit regulatory documentation for Class III (PMA) devices and Class II (510(k)) devices. Liaise with regulatory agencies to facilitate the review process.
- Compliance Management - Monitor and interpret changes to standards and regulations. Manage ongoing compliance. Collaborate with internal teams to address potential compliance gaps.
- Risk Management - Collaborate with crossfunctional teams to execute the Risk Management Process and Benefit-Risk Determinations.
- Maintain facility registrations in good standing.

Supervisory Responsibilities:
**Qualification Requirements**:
**Education**:
Bachelor’s degree in a scientific discipline or with relevant experience

**Experience**:
5+ years experience in medical device regulatory affairs.

Knowledge/Skill:

- In-depth knowledge of FDA regulations
- In-depth knowledge of international medical device standards
- Strong understanding of quality management systems
- Strong understanding of the regulatory submissions process
- Clear, open communication
- Ability to work collaboratively in a fast-paced environment
- Good interpersonal skills and ability to work with other departments
- Ability to work on-site

**Working Conditions**:
Duties of this position are performed in good working conditions. Occasional exposure to elements such as noise, dust, chemicals, operating machinery, temperature extremes, etc.