Regulatory Affairs Professional creating clinical evaluation documents for medical devices in a fast - growing biotech company. Collaborating with stakeholders and ensuring compliance with regulations.
About the role
- Risk and Compliance Advisor role focusing on SSLDC process and risk and control testing. Collaborating with teams to ensure compliance standards and operational efficiency.
Responsibilities
- Partners with key team members in the business to identify, assess, aggregate and document risk and compliance controls, including risks associated with new or modified products, services, distribution channels, regulations, and third-party operations
- Communicates results of risk and compliance work to governance committees, business process owners and various levels of leadership
- Contributes to the implementation of new risk and compliance policies, practices, appetites, and solutions to ensure well-rounded understanding and management of risks according to industry standard process
- Implements assigned risk or compliance activities in accordance with enterprise policies and procedures
- Maintains and expands knowledge of the competitive/regulatory landscape and the company's key challenges
- Reviews laws and regulations for business impact and makes proposals for awareness and action
- May coordinate and respond to regulatory requirements and requests and ensures the execution of examinations
- Performs work on risk and compliance processes that focus on improving strategies, tools, and methodologies to measure, monitor, and report risks
- Applies knowledge to assess data and produce analytical insights to understand business objectives, drive business decisions and influence solution strategies
- Actively contributes in cross-functional teams to identify, assess, aggregate, and mitigate current and emerging risk events
- Contributes to stress test plans for a line of business or the enterprise including the evaluation of results and framing of contingency plans in partnership with key business partners
Requirements
- Bachelor’s degree or 4 additional years of related experience beyond the minimum required may be substituted in lieu of a degree
- 4 years relevant experience in risk, compliance, legal or audit within the financial services or insurance industry or specialized technical fields directly related to the role
- Risk and/or compliance experience in a highly matrixed environment
- Knowledge of compliance laws, regulations, and regulatory expectations
- An ability to apply regulatory risk and compliance knowledge to consult and provide guidance
- An ability to challenge in business or team settings
- Effectively work with internal and external partners in a highly collaborative environment
- Critical thinking and knowledge of data analysis tools and techniques and decision-making abilities to recommend data-driven solutions
- Proactively identifies potential concerns and recommends solutions
- Proficiency with Microsoft Office products including Word, Excel, and PowerPoint
Benefits
- comprehensive medical, dental and vision plans
- 401(k)
- pension
- life insurance
- parental benefits
- adoption assistance
- paid time off program with paid holidays plus 16 paid volunteer hours
- various wellness programs
- career path planning and continuing education
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