Job description
We are seeking an outstanding professional for the position of Director, Regulatory Affairs. The successful candidate will work in close collaboration with others in the Clinical, Marketing, Medical & Scientific Affairs, Engineering and Operations functions. The successful candidate will have an opportunity to leverage their tenacity, professional skills and capabilities and reap the rewards associated with Auxogyn’s commercial success.
This position is responsible for the overall management and development of all Auxogyn regulatory policy and practice. Responsible for determining and pursuing courses of action necessary to obtain regulatory approval for significant or complex products. Provides leadership and management for meeting and defining departmental objectives and gives work direction on projects of large scale and complexity. Activities for this position are largely self-initiated. Auxogyn seeks candidates who will meet our customer expectations by striving without reserve for the greatest possible reliability and quality in our products, processes and systems by being accountable, having a voice, and taking action.
Major Duties and Responsibilities
Responsible for preparation of FDA submissions for new, more complex products as required to ensure appropriate clinical studies and timely market release.
Prepare regulatory strategies / plans and worldwide requirements lists. Provide leadership and serve as prime technical contact to product development teams for regulatory issues and questions on most complex products / projects.
Work on unusually complex technical problems and provides solutions which are highly innovative.
Provide business and product information to enable development of worldwide strategies and requirements, and communicate that information to business teams. Provide product and test information to support international submissions in major markets.
Negotiate directly with the FDA on all projects / products at all levels of the FDA organization.
Provide support to market-released products as necessary. This includes reviewing labeling, promotional material, product / manufacturing process changes and documentation for changes requiring government approval. Prepare submissions and reports for FDA and support other similar international agencies as required by product status.
Develop and influence government and regulatory policy in support of departmental objectives and as directed by manager.
Maintain Regulatory Affairs product files to support compliance with regulatory requirements.
Lead, manage and mentor other staff as required.
Develop and manage department budget
Desired Skills and Experience
Preferred Qualifications
Education and/or Job Experience:
Bachelor Degree in Engineering, Physical / Biological Sciences (or equivalent) with at least 15 years experience
Advanced Degree with more than 10 years medical device industry experience
Proficiency in Regulatory, Compliance, and Clinical Research
Regulatory Affairs Professional Society (RAPS) Certified
Statistical knowledge, hands-on experience developing and executing regulatory strategy; ability to interface with medical device international regulatory agencies; FDA relationship building capability, as well as managing on-going FDA planning and organizing requirements
Special Skills, Abilities, and Requirements:
Must have strong working knowledge of requirements of regulatory agencies and be familiar with clinical research
Experience in infertility technology a plus, but not required
Must have strong communication, interpersonal skills and attention to detail
Proven ability to successfully, collaboratively work in a matrixed organization
Excellent project management skills
Experience in the management of a fast-paced, multi-center clinical trial
Highly motivated with excellent work ethics
Proficient in computer skills (Microsoft Office products, Word, Excel, etc.)
Background in women’s health is strongly preferred
Must be able to travel at least 50% of the time (USA and International)
Demonstrated Personal Characteristics
Candidate must be driven to deliver results with the ability to establish rapport, earn trust, and effectively collaborate with others. Essential attributes of the successful candidate is one who:
Is Action Oriented:
Motivated by results
Full of energy when faced with challenges
Able to make and implement tough decisions
“Proactive” as opposed to “reactive”
Deals with Ambiguity:
Can be flexible and adaptable in a complex, changing environment
Can comfortably handle risk and uncertainty
Works Collaboratively:
Practices attentive and active listening
Has the patience to hear people out and to search for constructive input
Exemplifies Interpersonal Savvy and Integrity:
Relates well to all kinds of people—both inside and outside the company
Builds constructive and effective relationships
Uses diplomacy and tact
Adheres to an appropriate set of core values and beliefs
Always acts with uncompromising integrity
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