Principal Regulatory Affairs Specialist

Description

Represents the Regulatory Affairs function in project teams and leads regulatory projects in accordance with established timelines to meet corporate objectives. Develops and executes sound regulatory strategies to support business goals. Oversees and ensures compliance with state, federal, and international medical device regulations and overall regulatory departmental objectives for new and existing products. In addition, this position also assists with the training and mentoring of other Regulatory Affairs team members.

Essential duties and responsibilities include, but are not limited to, the following:

• Represents RA department in assigned project meetings and provides regulatory guidance to ensure adherence with global regulatory requirements as appropriate.
• In conjunction with project teams and international partners, evaluates possible pathways to marketing authorization and recommends pathway that appropriately weighs the probability of success with potential risks to the business. With minimal Regulatory Affairs management oversight, develops and executes sound regulatory strategies to support business goals.
• Independently assesses product and manufacturing changes and develops well-justified regulatory assessments for each global market.
• Reviews and approves document change orders, advertising and promotional material, manufacturing nonconformances, technical documents, test protocols and reports, risk management documents, labeling documents, and other documents as a key member of assigned project teams and ongoing sustaining support.
• Directly interacts with regulatory bodies in the US and/or international regions in a respectful, professional manner to ensure projects remain on track and issues are identified and resolved as expediently as possible.
• Develops, prepares, and submits high quality technical documentation/submissions for regulatory approval in the US and other international regions. Establishes timelines, manages sub-team meetings relevant to the regulatory processes, and ensures timely execution.
• Prepares reports for management and develops metrics and proposals for regulatory process improvements.
• Represents the Regulatory Affairs function in internal and external audits. Serves as regulatory subject matter expert for areas related to project responsibilities. Provides support for external audit activities as needed.
• Proactively maintains up-to-date knowledge on applicable domestic and international regulatory requirements and effectively communicates requirements to project teams and management.
• Assign and oversee completion of prioritized tasks to junior Regulatory Affairs team members, as appropriate.
• Updates departmental procedures as required.

Other Duties and Responsibilities

• Other duties as assigned.

Education and

Required Experience:

• Bachelor's degree in a scientific, engineering, or technical discipline is required.
• Minimum 7 years of directly relevant Regulatory Affairs experience within the medical device or other regulated industry.
• An advanced degree may supplement some professional experience.
• Experience with Class III active implantable medical devices is preferred.

Knowledge, Skills, and Abilities:

• Strong knowledge of US and international medical device regulations. Ability to interpret regulatory requirements and provide actionable guidance to cross-functional team members.
• Demonstrated experience with successful submissions and strategic planning.
• Effectively uses all mediums of communication as appropriate, presents well to groups, actively listens, and continuously identifies opportunities to build communication skills.
• Actively works together with formal and informal team members to build relationships and achieve team goals.
• Effectively manages multiple assignments and prioritizes work to ensure timely completion of work within scope.
• Continuously builds functional and technical expertise and proactively applies that technical expertise in progressively broader scope.
• Focuses on results, takes initiative without direction, takes ownership for all work within scope, builds relationships and works across departments, functions, or areas of responsibility.
• Actively seeks to understand perspectives and interpersonal needs and expectations of others at all levels, builds self-awareness, flexes personal style appropriately, and works through conflicts constructively and appropriately.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Ability to work in collaborative and independent work situations and environments with minimal supervision.

Physical Requirements:

• Willingness and able to travel approximately 10% of the time. Travel may include weekends and overnight stay.
• Required to stand, walk and sit; talk or hear; use hands to finger, handle or feel objects or controls; reach with hands and arms.…