Regulatory Affairs Manager

REGULATORY AFFAIRS MANAGER The Opportunity The function of a Regulatory Affairs Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. The individual has department/group/site level influence and is generally recognized as an expert resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed, obtain this data and ensure that they are effectively presented for the registration of products worldwide.

Responsibilities Regulatory Knowledge/Skills:

• Anticipate regulatory obstacles and emerging issues.

• Lead functional groups to complete a regulatory submission.

• Regulatory history, guidelines, policies, standards, practices, requirements and precedents

• Regulatory agency structure, processes and key personnel

• Principles and requirements of applicable product laws

• Principles and requirements of promotion, advertising and labeling

• Interpret and apply regulatory requirements. Compile, prepare, review and submit regulatory submissions to authorities.

• Domestic and international regulatory guidelines, policies and regulations

• Ethical guidelines of the regulatory profession, clinical research and regulatory process Communication:

• Communicate effectively verbally and in writing.

• Write and edit technical documents.

• Communicate and work with people from various disciplines and cultures.

• Negotiate internally and externally with regulatory agencies.

• Plan and conduct meetings; Work with cross-functional teams.

• Clearly explain and articulate Regulatory plans to Senior leaders.

Cognitive Skills:

• Define regulatory strategy

• Perform risk assessment or analysis.

• Juggle multiple and competing priorities.

• Think analytically with good problem-solving skills.

• Organize and track complex information.

• Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

• Has broad knowledge of various technical alternatives and their potential impact on the business.

• 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.

• Lead functional groups in the development of relevant data to complete a regulatory submission.

• Influencing others to a win/win resolution, appreciating all perspectives.

Leadership:

• Develops, communicates, and builds consensus for operating goals that are in alignment with the division.

• Provides leadership by communicating and providing guidance towards achieving business 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.

• Exercises judgment independently.

Required Qualifications:

• Bachelor’s Degree in technical discipline or an equivalent combination of education and experience.

• Minimum 6 years Regulatory experience

• Experience with 510(k) applications, IDEs, PMA or PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions.

• Ability to work in a highly matrixed and geographically diverse business environment.

• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

• Ability to leverage and/or engage others to accomplish projects.

• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

• Multitasks, prioritizes and meets deadlines in a timely manner.

• Strong organizational and follow-up skills, as well as attention to detail.

• Ability to work independently with no oversight.

• Ability to identify and solve problems in a strategic manner.

• Ability to manage complex projects.

• Ability to be proactive and not reactive, to anticipate changing business and regulatory environments.

Preferred Qualifications

• Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.

• Advanced degree

• 8 years’ Regulatory experience

• Experience working in a broader enterprise/cross-division business unit model.

• Demonstrated experience at a supervisory/managerial level.

• Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies.

• Experience with medical device software requirements and software regulations.

• Ability to identify risk areas and escalate issues as appropriate.

• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).