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Remote Prin Regulatory Affairs Spec
8200 Coral Sea Street Northeast New Brighton, MN 55112 US
Job Description
Must Have
- Advertising and Promotional Regulatory Assessment experience, change control, and US/EU submission experience
Nice To Have
- regulatory assessment of change orders emphasis on US and EU, experience with MAP Agile, Familiar with ISO 13485, FDA Medical Devices Part 820 and medical Device Good Documentation Practices
Responsibilities may include the following and other duties may be assigned. Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company internal audits and inspections. Leads or compiles all materials required in submissions license renewal and annual registrations. Recommends changes for labeling manufacturing marketing and clinical protocol for regulatory compliance. Monitors and improves tracking / control systems. Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications.
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies using specialized knowledge and skills normally acquired through advanced education typically University.
DIFFERENTIATING FACTORS
Autonomy: Recognized expert managing large projects or processes . Exercises considerable latitude in determining deliverables of assignments with limited oversight from manager . Coaches reviews and delegates work to lower level specialists.
Organizational Impact: Contributes to defining the direction for new products processes standards or operational plans based on business strategy with a significant impact on work group results . May manage large projects or processes that span outside of immediate job area.
Innovation and Complexity: Problems and issues faced are difficult moderately complex and undefined and require detailed information gathering analysis and investigation . Develops solutions to moderately complex problems and/or makes moderate to significant improvements of processes systems or products independently to enhance performance of job area. Implements solutions to problems.
Communication and Influence: Represents organization as a primary contact for specific projects and initiatives communicates with internal and external customers and vendors at various levels . May negotiate with others to reach understanding or agreement and influence decisionmaking.
Leadership and Talent Management: Typically provides guidance coaching and training to other employees within job area. Typically manages major / moderately complex projects involving delegation of work and review of work products at times acting as a team leader.
Required Knowledge and Experience: Requires mastery of a specialty area and full knowledge of industry practices typically obtained through advanced education combined with experience. May have broad knowledge of project management. Requires a University Degree and minimum 7 years of relevant experience or advanced degree with a minimum of 5 years of relevant experience.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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