- Develop new regulatory policies, processes and SOPs and train key personnel on them. Evaluate regulatory risks of division policies, processes, procedures. Recruit, develop and manage regulatory professionals.
- Provide regulatory input to product lifecycle planning. Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management. Provide strategic input and technical guidance on regulatory requirements to development teams.
- Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes.
- Assist in regulatory due diligence for potential and new acquisitions.
- Utilize technical regulatory skills to propose strategies on complex issues. Determine submission and approval requirements. Identify emerging issues.
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams. Monitor trade association positions for impact on company products.
- Assess the acceptability of quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submission to authorities.
- Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions.
- Monitor impact of changing regulations on submission strategies and update internal stakeholders. Monitor applications under regulatory review. Communicate application progress to internal stakeholders. Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities.
- Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
- Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.
- Manage and execute preapproval compliance activities.
- Oversee processes involved with maintaining annual licenses, registrations, listings and patent information. Ensure compliance with product post-marketing approval requirements. Review and approve advertising and promotional items to ensure regulatory compliance. Ensure external communications meet regulations.
- Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events. Actively contribute to the development and functioning of the crisis/issue management program. Analyze product-associated problems and develop proposals for solutions.
- Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies. Report adverse events to regulatory agencies and internal stakeholders. Provide regulatory input for product recalls and recall communications.
- Individuals execute and manage technical and scientific regulatory activities. Must function independently as a decision-maker on regulatory issues and must assure that deadlines are met.
- Work is performed without appreciable direction and exercises some latitude in determining technical objectives of assignments. Completed work is reviewed from a relatively long- term perspective for desired results. Individual is recognized as a discipline expert and resource in regulatory affairs.
- Develops, communicates, and builds consensus for operating goals that are in alignment with the division. Provides leadership by communicating and providing guidance towards achieving department objectives. Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units. May lead a cross-functional or cross-divisional project team. Provides technical leadership to business units. Acts as a mentor to less-experienced staff. Exercises judgment independently.
- Creates immediate to long-range plans to carry out objectives established by top management. Develops and calculates a budget for a department or group to meet organizational goals. Forecasts future needs including human and material resources and capital expenditures. Recommends or modifies the structure of organizational units or a centralized functional activity subject to senior management approval.
- Assignments are expressed in the form of objectives Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management. Consequences of erroneous decisions or recommendations would normally include critical delays and modifications to projects or operations with substantial expenditure of time, human resources, and funds, and may jeopardize future business activity.
- Bachelor's degree (or equivalent)
- 4-5 years' experience in a regulated industry (e.g., medical products, nutritionals). Note: Higher education may compensate for years of experience.
- 2-5 years of experience in regulatory preferred but may consider quality assurance, research and
- development/support, scientific affairs, operations, or related area.
- Effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with various regulatory agencies.
- Ability to work effectively on cross-functional teams.
- Pay strong attention to detail.
- Organize and track complex information.
- Exercise good and ethical judgment within policy and regulations
- Use in-depth knowledge of business functions and cross group dependencies/ relationships.
- Follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
- Bachelor's degree in science (biology; chemistry; microbiology; immunology; medical technology; pharmacy; pharmacology); math; engineering; or medical fields.
- M.S. in a technical area or MBA. A Ph.D. in a technical area or law is helpful.
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
- Previous experience with 510k / PMA submissions.
- Prior experience supervising and coaching a team.
- Experience with Medical Devices.
- Must be able to juggle multiple and competing priorities.
- Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Has a sound knowledge of a variety of alternatives and their impact on the business.
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Description
The Opportunity
The Regulatory Affairs Manager will work out of either our Plymouth, St. Paul or Maple Grove, MN locations for our Electrophysiology division. As a manager, the function of a Manager Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. This new team member will develop and supervise regulatory professionals as well as share knowledge and expertise with others in support of team activities. The individual has department/group/site level influence and is generally recognized as an expert and resource within the department. This Regulatory Affairs Manager may analyze broad scope implications of changing regulations and guidance. Additionally, may identify data needed, obtain this data, and ensure that they are effectively presented for the registration of products worldwide.
What You'll Work On
Required Qualifications
Preferred Qualifications
